Full List of Amlodipine Recalls, FDA 2012-2017

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There have been nine major Amlodipine recalls since 2012 and seven minor ones. There are actually 49 FDA recall orders for the popular generic, but that’s because each major recall is made up of several orders each. This drug has a much rockier recall history than most of the other most common generics. The biggest recall by far was a 2013 event from Novartis Pharmaceuticals that affected nearly 4.2 million bottles. That said, there are four other recalls in the 150,000+ range.

Finding info on any given Amlodipine recall can be challenging because of the way the FDA presents the data. Below, we’ve listed all 49 Amlodipine recalls to date, along with reasons, lot numbers, dates, manufacturers, and numbers of bottles involved.

Amlodipine Recalls

There are 49 total recalls of Amlodipine through 2017. They were either initiated by the manufacturers voluntarily or else ordered by the FDA.

The affected businesses for the nine major recalls are Lupin, Mylan, Dr. Reddy’s, Wockhardt, American Health Packaging, Novartis, and Walmart.

Minor recall firms are Health Innovations Pharmacy, Attix, Qualitest, Zydus, Daiichi Sankyo, Aidapak, and Legacy.

Nine of the recalls were relatively small. For example, a 2014 Amlodipine recall from Aidapak Services involved 180 tablets. That recall started with a labeling mixup.

See the full list of all Amlodipine recalls for 2012 through 2017 below.

Amlodipine Facts

Via: NIH.gov

Amlodipine is a high blood pressure drug called a calcium channel blocker. It works by dilating the blood vessels to improve blood flow. It’s used in the treatment of conditions due to coronary artery disease, including angina. It’s sold under the brand name Norvasc.

Serious side effects of Amlodipine may include irregular heartbeat, increased chest pain, and swelling in the ankles or feet. More common side effects are fatigue, dizziness, nausea, and flushing.

Major Amlodipine Recalls

There were nine major recalls of Amlodipine from 2012 through 2017. Each of these recalls affected over 20,000 bottles of the drug. They derived from various companies, including Novartis Pharmaceuticals, Walmart, Mylan Pharmaceuticals, Wockhardt USA, and Dr. Reddy’s Laboratories.

Several of the recalls were very large, spanning multiple FDA recall orders each. They’re bundled here by company and year.

There is another potentially large Amlodipine recall from Health Innovations Pharmacy that the FDA lists only as “all lots.” It’s impossible to judge the true size of that recall from FDA data.

Below is a bird’s eye view of all Amlodipine recalls so far. For a comprehensive list, scroll down.

  • 2016 Amlodipine recall: Approx. 459,000 bottles, Mylan Pharmaceuticals.
  • 2016 Amlodipine recall: Approx. 55,000 bottles, Lupin Pharmaceuticals.
  • 2015 Amlodipine recall: Approx. 299,000 bottles, Wockhardt USA.
  • 2015 Amlodipine recall: Approx. 173,000 bottles, Dr. Reddy’s Laboratories.
  • 2015 Amlodipine recall: Approx. 23,000 bottles, American Health Pharmacy.
  • 2015 Amlodipine recall: Several lots, Dr. Reddy’s Laboratories.
  • 2013 Amlodipine recall: Approx. 4.16 million bottles, Novartis Pharmaceuticals.
  • 2013 Amlodipine recall: Approx. 484,000 bottles, Walmart.
  • 2013 Amlodipine recall: Approx. 62,000 bottles, Mylan Pharmaceuticals.

Amlodipine Manufacturers

As a popular generic since 2007, Amlodipine is manufactured by dozens of companies. There’s a partial list of Amlodipine makers below.

  • Accord Healthcare
  • Mylan Pharmaceuticals
  • Novartis Pharmaceuticals
  • Qualitest Pharmaceuticals
  • Apotex
  • Dr. Reddy’s Laboratories
  • Lupin Pharmaceuticals
  • Invagen Pharmaceuticals
  • Polygen Pharmaceuticals
  • Sun Pharmaceuticals

Full List of All Amlodipine Recalls

Here’s the full list of all 49 Amlodipine FDA recalls through 2017. It includes multiple recall numbers for each major recall listed above. It also shows smaller recalls below 20,000 bottles each.

Class I, II, and III Recalls Explained

Amlodipine recalls are listed below in order of their FDA class numbers. For your reference, here’s a guide to the various classes:

Class I Recall. Urgent, with immediate danger of death or serious injury. None of the Amlodipine recalls shown here are Class I.

Class II Recall. Non-immediate risk of death or severe injury. 35 of the 49 Amlodipine recalls shown here are Class II.

Class III Recall. No immediate danger from FDA violations. 14 of the 49 FDA recall orders below are Class III.

About the Recall Dates Below

Below, each Amlodipine recall is shown by its classification date. In other words, it’s shown by the date the FDA classified it as Class I, II, or III. The first bullet point for each recall is its original issue date.

Via: NIH.gov

9/6/2016 Amlodipine Recall, Class III

  • Recall issued 2/19/2016.
  • 2.5 mg Amlodipine Besylate tablets, USP, 90-count bottles.
  • Manufacturer: Lupin Limited.
  • Reason: CGMP Deviations. Active ingredients failed specs.
  • 43,536 bottles recalled.
  • Lot # G304799.

9/6/2016 Amlodipine Recall, Class III

  • Recall issued 2/19/2016.
  • 10 mg Amlodipine Besylate tablets USP, 1,000-count bottles.
  • Manufacturer: Lupin Limited
  • Reason: CGMP Deviations. Active ingredients failed specs.
  • 11,812 bottles recalled.
  • Lot # G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534.

8/23/2016 Amlodipine Recall, Class II

  • Recall issued 9/17/2013.
  • 2.5 mg Amlodipine Besylate tablets in 100-count and 30-count cartons.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: CGMP Deviations. Active ingredients weren’t manufactured with Good Manufacturing Practices.
  • 9,156 and 521,310 cartons recalled.
  • Lot # 3039792, 3037880, 3043938, 3036811, 3037514, 3039975, 3042583.

8/23/2016 Amlodipine Recall, Class II

  • Recall issued 9/17/2013.
  • 5 mg Amlodipine Besylate tablets in 25-count, 30-count, 100-count, and 300-count cartons.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: CGMP Deviations. Active ingredients weren’t manufactured with Good Manufacturing Practices.
  • 42,733, 3,267, 10,303, 4,262,856 cartons recalled.
  • Lot # 3038339, 3043618, 3041862, 3044258, 2120031, 2120067, 3035787, 3035834, 3035835, 3037125, 3037126, 3037127, 3037511, 3037512, 3037513, 3038113, 3038114, 3038115, 3038116, 3039641, 3039642, 3039643, 3039974, 3040567, 3040977, 3041253, 3041800, 3041801, 3042446, 3042624, 3043015, 3043401, 3043466, 3044590, 09/14 3044591, 3045063, 3045064.

8/23/2016 Amlodipine Recall, Class II

  • Recall issued 9/17/2013.
  • 10 mg Amlodipine Besylate tablets in 25-count, 100-count, and 300-count cartons.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: CGMP Deviations. Active ingredients weren’t manufactured with Good Manufacturing Practices.
  • 11,064, 2,052, 5,567 cartons recalled.
  • Lot # 3039795, 3042896, 3039793, 3042892, 2120054, 2120090.

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10/9/2015 Amlodipine Recall, Class II

  • Recall issued 2/12/2015.
  • 0.625 mg/ 0.1 ml Amlodipine Vet Gel.
  • Manufacturer: Health Innovations Pharmacy, Inc.
  • Reason: Possible contamination.
  • All lots.

8/27/2015 Amlodipine Recall, Class III

  • Recall issued 8/13/2015.
  • 2.5 mg/ 10 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count bottles.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • 1,056 bottles recalled.
  • Lot # C403575.

8/27/2015 Amlodipine Recall, Class III

  • Recall issued 8/13/2015.
  • 2.5 mg/ 20 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count bottles.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • 576 bottles recalled.
  • Lot # C403574.

8/27/2015 Amlodipine Recall, Class III

  • Recall issued 8/13/2015.
  • 2.5 mg/ 40 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count bottles.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • 984 bottles recalled.
  • Lot # C402341.

8/27/2015 Amlodipine Recall, Class III

  • Recall issued 8/13/2015.
  • 5 mg/ 20 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count and 90-count bottles.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • 14,640 and 624 bottles recalled.
  • Lot # C403577, C403577.

8/27/2015 Amlodipine Recall, Class III

  • Recall issued 8/13/2015.
  • 10 mg/ 20 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count and 90-count bottles.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • 16,080 and 480 bottles recalled.
  • Lot # C404592, C404592.

8/27/2015 Amlodipine Recall, Class III

  • Recall issued 8/13/2015.
  • 10 mg/ 40 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count and 90-count bottles.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • 16,848 and 216 bottles recalled.
  • Lot # C409650, C409652, C409652.

8/27/2015 Amlodipine Recall, Class III

  • Recall issued 8/13/2015.
  • 10 mg/ 80 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count bottles.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • 3840 bottles recalled.
  • Lot # C404595.

7/17/2015 Amlodipine Recall, Class II

  • Recall issued 4/22/2015.
  • 2.5 mg Amlodipine Besylate tablets, 90-count bottles.
  • Manufacturer: Wockhardt Limited.
  • Reason: CGMP Deviations. Inadequate investigation of customer complaints by firm.
  • 124,034 bottles recalled.
  • Lot # DM11774, DM13056, DM13117, DM13159, DM13186, DM13187, DM13188, DN10003, DN10045, DN10046, DN10389, DN10412, DN10604.

7/17/2015 Amlodipine Recall, Class II

  • Recall issued 4/22/2015.
  • 5 mg Amlodipine Besylate tablets, 90-count and 1,000-count bottles.
  • Manufacturer: Wockhardt Limited.
  • Reason: CGMP Deviations. Inadequate investigation of customer complaints by firm.
  • 146,959 bottles, B) 73,445 bottles recalled.
  • Lot # DM11421, DM12956, DM12957, DM12963, DM13242, DM13243, DM13251, DM13260, DN10138, DM11035, DM11088, DM11389, DM11393, DM11394, DM12632, DM12633, DM12650, DM12651, DM12667, DM12964, DM13086, DM13155, DM13156, DM13157, DM13158, DM13184, DM13206, DM13207, DM13266, DM13267, DM13268, DM13283, DM13325, DN10058, DN10059, DN10060, DN10061, DN10062, DN10307, DN10308, DN10324, DN10346, DN10809, DN10810, DN10840, DN10877, DN10878, DN10904, DN10905, DN10921, DN10942, DN10943, DN10972.

7/17/2015 Amlodipine Recall, Class II

  • Recall issued 4/22/2015.
  • 10 mg Amlodipine Besylate tablets, 90-count and 1,000-count bottles.
  • Manufacturer: Wockhardt Limited.
  • Reason: CGMP Deviations. Inadequate investigation of customer complaints by firm.
  • 152,164, 50,991 bottles recalled.
  • Lot # DM12975, DM12976, DM12977, DM12986, DM13259, DM13269, DM13270, DM13275, DM13339, DM13341, DM13369, DM13370, DN10088, DN10099, DN10939, DN10940, DM11423, DM11424, DM11425, DM12634, DM12635, DM12660, DM12661, DM12662, DM12663, DM12673, DM12674, DM12684, DM12685, DM12985, DM13162, DM13163, DM13195, DM13196, DM13222, DM13223, DM13271, DM13272, DM13273, DM13274, DM13281, DM13282, DM13296, DM13297, DM13393, DM13394, DM13395, DM13403, DM13404, DM13415, DM13429, DN10077, DN10078, DN10079, DN10080, DN10081, DN10100, DN10104, DN10105, DN10336, DN10342, DN10343, DN10344, DN10355, DN10356, DN10811, DN10812, DN10830, DN10874, DN10875, DN10876, DN10890, DN10891, DN10938, DN10956.

7/8/2015 Amlodipine Recall, Class II

  • Recall issued 6/1/2015.
  • 2.5 mg Amlodipine Besylate tablets, 10-count blisters, 10 blister packs per carton.
  • Manufacturer: Wockhardt Limited.
  • Reason: CGMP Deviations. Inadequate investigation of customer complaints by firm.
  • 1,896 cartons recalled.
  • Lot # 131924.

7/8/2015 Amlodipine Recall, Class II

  • Recall issued 6/1/2015.
  • 5 mg Amlodipine Besylate tablets, 10-count blisters, 10 blister packs per carton.
  • Manufacturer: Wockhardt Limited.
  • Reason: CGMP Deviations. Inadequate investigation of customer complaints by firm.
  • 20,855 cartons recalled.
  • Lot # 131954, 131955.

7/8/2015 Amlodipine Recall, Class II

  • Recall issued 6/1/2015.
  • 10 mg Amlodipine Besylate tablets, 10-count blisters, 10 blister packs per carton.
  • Manufacturer: Wockhardt Limited.
  • Reason: CGMP Deviations. Inadequate investigation of customer complaints by firm.
  • 1,745 cartons recalled.
  • Lot # 131953.
Via: NIH.gov

6/18/2015 Amlodipine Recall, Class III

  • Recall issued 5/6/2015, terminated 3/31/2016.
  • 5 mg/ 10 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count and 90-count bottles.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • Lot # C401536, C401538.

6/18/2015 Amlodipine Recall, Class III

  • Recall issued 5/6/2015, terminated 3/31/2016.
  • 10 mg/ 10 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count and 90-count bottles.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • Lot # C401537, C401539.

6/18/2015 Amlodipine Recall, Class III

  • Recall issued 5/6/2015, terminated 3/31/2016.
  • 10 mg/ 40 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 90-count bottle.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • Lot # C309280.

6/18/2015 Amlodipine Recall, Class III

  • Recall issued 5/6/2015, terminated 3/31/2016.
  • 5 mg/ 40 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count and 90-count bottles.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • Lot # C402439.

4/20/2015 Amlodipine Recall, Class II

  • Recall issued 11/14/2014, terminated 10/7/2015.
  • Varying amounts of Amlodipine, a pharmaceutical ingredient.
  • Manufacturer: Attix Pharmaceuticals.
  • Reason: Possible penicillin cross-contamination.
  • 1,000 grams recalled.
  • All lots repackaged/distributed 1/5/12 to 2/12/15.

4/20/2015 Amlodipine Recall, Class II

  • Recall issued 11/14/2014, terminated 10/7/2015.
  • Varying amounts of Amlodipine Besylate, a pharmaceutical ingredient.
  • Manufacturer: Attix Pharmaceuticals.
  • Reason: Possible penicillin cross-contamination.
  • 5,200 grams recalled.
  • All lots repackaged/distributed 1/5/12 to 2/12/15.

3/3/2015 Amlodipine Recall, Class II

  • Recall issued 2/13/2015, terminated 1/27/2016.
  • 10 mg Amlodipine Besylate tablets, USP, 1,000-count bottles.
  • Manufactured for: Qualitest Pharmaceuticals.
  • Reason: One lot contained oversized tablets.
  • 2808 bottles recalled.
  • Lot # T018H14A.

11/21/2014 Amlodipine Recall, Class III

  • Recall issued 10/1/2014, terminated 2/26/2016.
  • 10 mg Amlodipine Besylate tablets, USP, 90 tablets per bottle
  • Manufacturer: Cadila Healthcare Ltd.
  • Reason: Discoloration. Brown spots found in tablet.
  • 15,144 bottles recalled.
  • Lot # MP4344.

7/31/2014 Amlodipine Recall, Class II

  • Recall issued 7/12/2014, terminated 3/16/2015.
  • 10 mg/ 40 mg Amlodipine, Olmesartan Medoxomil (Azor) tablets, 30-count bottles.
  • Manufactured for: Daiichi Sankyo, Inc.
  • Reason: Product temperature not controlled during shipping.
  • 5 bottles recalled.
  • Lot # 213655B.

7/31/2014 Amlodipine Recall, Class II

  • Recall issued 7/12/2014, terminated 3/16/2015.
  • 40 mg/ 5 mg/ 25 mg Olmesartan Medoxomil/ Amlodipine/ Hydrochlorothiazide (Tribenzor) tablets, 30-count bottles.
  • Manufactured for: Daiichi Sankyo, Inc.
  • Reason: Product temperature not controlled during shipping.
  • Lot # 211836.

1/20/2014 Amlodipine Recall, Class II

  • Recall issued 7/2/2013, terminated 2/7/2014.
  • 5 mg Amlodipine Besylate tablet.
  • Distributed by: AidaPak Service, LLC.
  • Reason: Label Mixup: May be mislabeled as Cyanocobalamin.
  • 90 Tablets recalled.
  • Pedigree: W002840.

1/16/2014 Amlodipine Recall, Class II

  • Recall issued 7/2/2013, terminated 2/7/2014.
  • 10 mg Amlodipine Besylate tablet.
  • Distributed by: AidaPak Service, LLC.
  • Reason: Label Mixup: May be mislabeled as Finasteride.
  • 90 Tablets recalled.
  • Pedigree: AD62846_4.

12/6/2013 Amlodipine Recall, Class II

  • Recall issued 8/8/2013, terminated 12/21/2015.
  • 5 mg/ 160 mg Exforge (Amlodipine and Valsartan), 7 tablets per bottle.
  • Manufacturer: Novartis Pharma Stein AG.
  • Reason: Contamination with Darocur 1173 photocuring agent.
  • 1,492,475 bottles recalled.
  • Lot # F0048A, F0056A, F0084, F0085, F0059A, F0088, F0086, F0087, F0061A, F0063W1, F0070A, F0082A.

12/6/2013 Amlodipine Recall, Class II

  • Recall issued 8/8/2013, terminated 12/21/2015.
  • 5 mg/ 320 mg Exforge (Amlodipine and Valsartan), 7 tablets per bottle.
  • Manufacturer: Novartis Pharma Stein AG.
  • Reason: Contamination with Darocur 1173 photocuring agent.
  • 869,951 bottles recalled.
  • Lot # F0102, F0115, F0116, F0105, F0109, F0111, F0112, F0121, F0122, F0125A, F0125W1, F0137, F0139, F0140, F0141, F0142, F0144.

12/6/2013 Amlodipine Recall, Class II

  • Recall issued 8/8/2013, terminated 12/21/2015.
  • 10 mg/ 320 mg /25 mg Exforge HCT (Amlodipine, Valsartan, Hydrochlorothiazide), 7 tablets per bottle.
  • Manufacturer: Novartis Pharma Stein AG.
  • Reason: Contamination with Darocur 1173 photocuring agent.
  • 281,935 bottles recalled.
  • Lot # F0034, F0035, F0036, F0036A, F0038, F0039, F0040, F0041, F0042, F0043, F0045, F0044, F0046.

12/6/2013 Amlodipine Recall, Class II

  • Recall issued 8/8/2013, terminated 12/21/2015.
  • 5 mg/ 160 mg/ 12.5 mg Exforge HCT (Amlodipine, Valsartan, Hydrochlorothiazide), 7 tablets per bottle.
  • Manufacturer: Novartis Pharma Stein AG.
  • Reason: Contamination with Darocur 1173 photocuring agent.
  • 328,543 bottles recalled.
  • Lot # F0019, F0019A, F0020, 09/30/2013 F0021, F0021A, F0022, F0025, F0024, F0026, F0027.

12/6/2013 Amlodipine Recall, Class II

  • Recall issued 8/8/2013, terminated 12/21/2015.
  • 5 mg/ 160 mg/ 25 mg Exforge HCT (Amlodipine, Valsartan, Hydrochlorothiazide), 7 tablets per bottle.
  • Manufacturer: Novartis Pharma Stein AG.
  • Reason: Contamination with Darocur 1173 photocuring agent.
  • 174,848 bottles recalled.
  • Lot # F0012, F0013, F0014.

12/6/2013 Amlodipine Recall, Class II

  • Recall issued 8/8/2013, terminated 12/21/2015.
  • 10 mg/ 160 mg Exforge (Amlodipine and Valsartan), 7 tablets per bottle.
  • Manufacturer: Novartis Pharma Stein AG.
  • Reason: Contamination with Darocur 1173 photocuring agent.
  • 61,1240 bottles recalled.
  • Lot # F0060, F0028A, F0061, F0062, F0033A, F0037A.

12/6/2013 Amlodipine Recall, Class II

  • Recall issued 8/8/2013, terminated 12/21/2015.
  • 10 mg/ 320 mg Exforge (Amlodipine and Valsartan), 7 tablets per bottle.
  • Manufacturer: Novartis Pharma Stein AG.
  • Reason: Contamination with Darocur 1173 photocuring agent.
  • 951,109 bottles recalled.
  • Lot # F0131, F0138, F0137, F0139, F0140, F0141, F0142, F0142A, F0145, F0150, F0157, F0158, F0159, F0160, F0163, F0165, F0184.

11/4/2013 Amlodipine Recall, Class II

  • Recall issued 9/13/2013, terminated 7/23/2015.
  • 2.5 mg Amlodipine Besylate tablets, USP, 90-count and 500-count bottles.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: CGMP Deviations. Active ingredients weren’t manufactured with Good Manufacturing Practices.
  • 37,752 bottles recalled.
  • Lot # 3037907, 3040106 3037907, 3040106, 3044357.

11/4/2013 Amlodipine Recall, Class II

  • Recall issued 9/13/2013, terminated 7/23/2015.
  • 2.5 mg/ 10 mg Amlodipine Besylate, Benazepril HCl capsules, 100-count bottles.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: CGMP Deviations. Active ingredients weren’t manufactured with Good Manufacturing Practices.
  • 4,722 bottles recalled.
  • Lot # 2003156, 2003157, 2003155, 3043491.

11/4/2013 Amlodipine Recall, Class II

  • Recall issued 9/13/2013, terminated 7/23/2015.
  • 5 mg Amlodipine Besylate tablets, USP, 90-count and 500-count bottles.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: CGMP Deviations. Active ingredients weren’t manufactured with Good Manufacturing Practices.
  • 167,866 bottles recalled.
  • Lot # 3036490, 3036491, 3036492, 3039874 3036493, 3036494, 3039872, 3039873, 3041476, 3041477, 3044555, 3044683.

11/4/2013 Amlodipine Recall, Class II

  • Recall issued 9/13/2013, terminated 7/23/2015.
  • 5 mg/ 10 mg Amlodipine Besylate, Benazepril HCl capsules, 100-count and 500-count bottles.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: CGMP Deviations. Active ingredients weren’t manufactured with Good Manufacturing Practices.
  • 30,878 bottles recalled.
  • Lot # 2003159, 2003160, 2003161, 3043492 2003158, 2003159, 3043492.

11/4/2013 Amlodipine Recall, Class II

  • Recall issued 9/13/2013, terminated 7/23/2015.
  • 5 mg/ 20 mg Amlodipine Besylate, Benazepril HCl capsules, 100-count and 500-count bottles.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: CGMP Deviations. Active ingredients weren’t manufactured with Good Manufacturing Practices.
  • 60,506 bottles recalled.
  • Lot # 2003169, 2003170, 2003171, 2003172, 2003173, 3043493 2003168, 2003169, 3043493.

11/4/2013 Amlodipine Recall, Class II

  • Recall issued 9/13/2013, terminated 7/23/2015.
  • 5 mg/ 40 mg Amlodipine Besylate, Benazepril HCl capsules, 100-count and 500-count bottles.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: CGMP Deviations. Active ingredients weren’t manufactured with Good Manufacturing Practices.
  • 11,701 bottles recalled.
  • Lot # 2003184, 2003185, 2003186, 3043495.
Via: NIH.gov

11/4/2013 Amlodipine Recall, Class II

  • Recall issued 9/13/2013, terminated 7/23/2015.
  • 10 mg/ 20 mg Amlodipine Besylate, Benazepril HCl capsules, 100-count and 500-count bottles.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: CGMP Deviations. Active ingredients weren’t manufactured with Good Manufacturing Practices.
  • 42,174 bottles recalled.
  • Lot # 2003177, 2003178, 2003179, 2003180, 3043496 2003176, 2003177, 3043496.

11/4/2013 Amlodipine Recall, Class II

  • Recall issued 9/13/2013, terminated 7/23/2015.
  • 10 mg/ 40 mg Amlodipine Besylate, Benazepril HCl capsules, 100-count bottles.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: CGMP Deviations. Active ingredients weren’t manufactured with Good Manufacturing Practices.
  • 23,356 bottles recalled.
  • Lot # 2003188, 2003189, 2003190, 2003191, 3043498.

11/4/2013 Amlodipine Recall, Class II

  • Recall issued 9/13/2013, terminated 7/23/2015.
  • 10 mg Amlodipine Besylate tablets, USP, 90-count and 500-count bottles.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: CGMP Deviations. Active ingredients weren’t manufactured with Good Manufacturing Practices.
  • 101,450 bottles recalled.
  • Lot # 3038984, 3038985, 3038986, 3041484, 3041485 3036828, 3036829, 3036830, 3036831, 3036832, 3038987, 3038988, 3038989, 3038990, 3041480, 3041481, 3041482, 3041483, 3044522, 3044525.

5/16/2013 Amlodipine Recall, Class II

  • Recall issued 4/22/2013, terminated 2/13/2014.
  • 10 mg Amlodipine Besylate tablets, USP, 30 tablets.
  • Manufacturer: InvaGen Pharmaceuticals, Inc.
  • Reason: Incorrect declared strength on label.
  • 484,236 cartons recalled.
  • Lot # 130251, 130252, 130253.

7/31/2012 Amlodipine Recall, Class II

  • Recall issued 4/9/2012, terminated 1/24/2013.
  • 5 mg/ 20 mg Amlodipine Besylate and Benazepril Hydrochloride, 500 capsules.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Mislabeled bottles.
  • 1656 bottles recalled.
  • C201293.

Conclusion

The list above simplifies the nine major Amlodipine recalls as of 6/26/17, with 49 recalls total. The biggest event from 2016 affected Novartis Pharmaceuticals. The next biggest was 2013’s Walmart recall, affecting over 484,000 bottles. The most recent is Lupin’s 2016 recall of 55,000+ bottles.

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Disclosure: the images on this page are for illustration only and don’t necessarily reflect recalled products.

 

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