Full List of All Lisinopril Recalls, FDA 2012-2017

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To date there have been six major recalls of Lisinopril and several minor ones. The largest was the 2015 recall from Wockhardt Pharmaceuticals, involving over 1.4 million bottles of different dosages and tablet counts.

Finding information on a given Lisinopril recall can be a little daunting, thanks to the way the FDA presents its information. Below, we’ve made it easy to find info on all recalls of this popular drug, including dates, manufacturers, number of bottles affected, lot numbers, and the reason given for each recall.

Lisinopril Recalls

There have been 29 total recalls of Lisinopril from 2012 through 2017. The recalls were either issued voluntarily by the manufacturer or mandated by the FDA.

The businesses affected were Accord Healthcare, Lupin Pharmaceuticals, Sandoz, Wockhardt, Qualitest, Attix, AidaPak, West-ward, Olympia Pharmacy, Aurobindo Pharma, Mylan, and GSMS.

Many of the recalls were minor. For instance, in one case, a pharmacy in Florida filled one 20 mg injection of Lisinopril incorrectly. In other cases, the FDA issued multiple recalls against the same company for different dosage sizes, though all the recalls originated from a single manufacturing error.

The full list of all Lisinopril recalls from 2012 through 2017 is below.

Lisinopril Facts

Via: NIH.gov
Lisinopril is an Angiotensin Converting Enzyme inhibitor or ACE inhibitor. It’s used for treating hypertension, blood cholesterol, pain, rheumatoid arthritis, and several other conditions. It goes by the brand names Qbrelis, Prinivil, and Zestril.

Serious side effects of Lisinopril include chest pain, jaundice, flu-like symptoms, and confusion. It can be hazardous if given to patients with diabetes, pregnant or nursing women, or people with liver disease, heart disease, or kidney disease.

Looking for a full page on all Lisinopril facts? Check out our Lisinopril facts page here.

Major Lisinopril Recalls

Via: NIH.gov
There were six major recalls of Lisinopril from 2012 through 2017. Each one involved more than 5,000 bottles of the drug. They originated from various companies, including Accord Healthcare, Lupin Pharmaceuticals, Wockhardt, Qualitest, Attix, and West-ward Pharmaceutical corp.

Some of the recalls were extremely large and spanned several actual FDA recall cases. We’ve grouped them by company and by year.

Below is a top-level view of all Lisinopril recalls to date. For the complete view, scroll down to the sections below.

  • 2017 Lisinopril recall: Approx. 12,000 bottles, Accord Healthcare.
  • 2016 Lisinopril recall: Approx. 110,000 bottles, Lupin Pharmaceuticals.
  • 2015 Lisinopril recall: Approx. 1.44 million bottles, Wockhardt Pharmaceuticals.
  • 2015 Lisinopril recall: Approx. 8,700 bottles, Qualitest
  • 2015 Lisinopril recall: Several lots, Attix Pharmaceuticals
  • 2012-2013 Lisinopril recall: Approx. 126,000 bottles, West-ward Pharmaceutical Corp.

Lisinopril Manufacturers

Dozens of companies make Lisinopril. There’s a partial list here and in the list below.

  • RemedyRepack Inc.
  • Cardinal Health
  • Proficient Rx Lp
  • Major Pharmaceuticals
  • International Labs
  • Northwind Pharmaceuticals
  • Blenheim Pharmacal
  • Direct Rx
  • American Health Packaging
  • Rxchange Co.

Full List of All Lisinopril Recalls

Via: NIH.gov
Here’s the full list of all 29 FDA Lisinopril recalls to date. It includes several distinct recall numbers for some of the major recalls shown above. It also displays numerous smaller recalls, affecting less than 5,000 bottles each.

What’s the Difference Between a Class I, Class II, and Class III Recall?

Lisinopril recalls are shown by FDA class number. For reference, the three different types of recalls are defined here.

Class I Recall. Urgent. Significant, immediate danger of death or serious injury. Rare.

Class II Recall. Serious. Danger of death or serious injury, but not immediate. This type of FDA recall is preventative in nature. Most of the recalls below are Class II.

Class III Recall. Least serious. No immediate danger, but items are found in violation of FDA regulations. About a third of the recalls shown here are Class III.

To date, there have been no Class I recalls of Lisinopril.

Why is the “Recall Date” Different from the “Issued Date”?

The FDA classifies recalls by two different dates: issue date and classification date. Generally, the FDA (or the manufacturer) will issue a recall and then, at some later time, the FDA classifies the severity of the recall as Class I, Class II, or Class III. We’ve grouped all Lisinopril recalls by the date they were classified. We’ve also listed the issue date for each lower down.

Also see this page on Omeprazole recalls, and this one on Simvastatin recalls.

2/16/2017 Lisinopril Recall, Class II

  • Recall issued 12/20/16.
  • 5 mg Lisinopril tablets, 1000-count.
  • Manufacturer: Accord Healthcare
  • Reason: Failed specification. missing break line on the tablets.
  • 12,896 bottles recalled.
  • Lot # T04483, T04484, T06028, T08423.

4/6/2016 Lisinopril Recall, Class III

  • Recall issued 4/6/16.
  • 30 mg Lisinopril tablets, 500-count and 100-count bottles.
  • Manufactured for Lupin Pharmaceuticals.
  • Reason: CGMP Deviations. Manufactured using active ingredients whose intermediates failed specs.
  • 5,880 bottles recalled.
  • Batch # H303487, H303488, H303489.

6/24/2016 Lisinopril & Hydrochlorothiazide Recall, Class III

  • Recall issued 4/4/16.
  • 20 mg and 12.5 mg tablets, 100 count and 5000 count bottles.
  • Manufactured for Lupin Pharmaceuticals
  • Reason: CGMP Deviations. Active ingredients’ intermediates failed specs.
  • 20,556 bottles recalled.
  • Lot # H303459, H303460.

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6/24/2016 Lisinopril Recall, Class III

  • Recall issued 4/4/16.
  • 40 mg Lisinopril tablets, 1000-count bottle.
  • Manufactured for: Lupin Pharmaceuticals.
  • Reason: CGMP Deviations. Active ingredients’ intermediates failed specs.
  • 59,520 bottles recalled.
  • Batch # H303449.

Via: NIH.gov

6/16/2016 Lisinopril Recall, Class III

  • Recall issued 5/25/16.
  • 30 mg Lisinopril tablets 100-count bottle.
  • Manufacturer: Sandoz Inc.
  • Reason: Labeling: Missing or incorrect package insert.
  • 3,048 bottles recalled.
  • Lot # FC1960.

6/24/2016 Lisinopril Recall, Class III

  • Recall issued 4/4/16.
  • 40 mg Lisinopril tablets, 1000 count bottle.
  • Manufactured for Lupin Pharmaceuticals.
  • Reason: CGMP Deviations. Active ingredients’ intermediates failed specs.
  • 5,880 bottles recalled.
  • Lot #: H303449.

6/24/16 Lisinopril Recall, Class III

  • Recall issued 4/4/16.
  • 30 mg Lisinopril tablets, 500 count bottle and 100 count bottle.
  • Manufactured for Lupin Pharmaceuticals.
  • Reason: CGMP Deviations. Active ingredients’ intermediates failed specs.
  • 20,587 bottles recalled.
  • Lot # H303487, H303488, H303489.

8/19/2015 Lisinopril Recall, Class II

  • Recall issued 7/29/15.
  • 20 mg Lisinopril tablets, 1000 count bottle.
  • Manufacturer: Wockhardt Ltd.
  • Reason: CGMP Deviations. FDA inspection revealed inadequate investigations of past complaints.
  • 3,378 bottles recalled.
  • Lot # DM13219, DM13428.

8/19/2015 Lisinopril Recall, Class II

  • Recall issued 7/29/15.
  • 5 mg Lisinopril tablets, 1000 count bottles.
  • Manufacturer: Wockhardt Ltd.
  • Reason: CGMP Deviations. FDA inspection revealed inadequate investigations of past complaints.
  • 1,704 bottles recalled.
  • Lot # DM12700.

Via: NIH.gov

9/1/2015 Lisinopril Recall, Class II

  • Recall issued 7/29/2015, terminated 3/29/16.
  • 40 mg Lisinopril tablets, 45 count bottle and 500 count bottle.
  • Manufactured for Qualitest Pharmaceuticals.
  • Reason: failed dissolution specs.
  • 8,705 bottles recalled.
  • Lot # C0570215B, C0570215A.

7/17/2015 Lisinopril Recall, Class II

  • Recall issued 4/22/15.
  • 40 mg Lisinopril tablets, 100 count, 500 count, and 1000 count bottles.
  • Manufacturer: Wockhardt, Ltd.
  • Reason: CGMP Deviations. Manufacturer didn’t provide adequate investigation of customer complaints.
  • 290,519 bottles recalled.
  • Lot # DM11040, DM11463, DM11497, DM11498, DM12126, DM12132, DM12172, DM12176, DN10325, DN10892, DM11812, DM11816, DM11821, DM11822, DM11827, DM11828, DM11853, DM11856, DM12517, DM12519, DM12528, DM12529, DM12534, DM12535, DM11018, DM11019, DM11028, DM11029, DM11049, DM11050, DM11468, DM11469, DM11480, DM11483, DM12095, DM12112, DM12129, DM12140, DM12141, DM12177, DM12499, DM12505, DM12509, DM12510, DM13306, DM13307, DM13313, DN10316, DN10332, DN10333, DN10348, DN10353, DN10369, DN10374, DN10375, DN10396, DN10854, DN10855, DN10872.

7/17/2015 Lisinopril Recall, Class II

  • Recall issued 4/22/15.
  • 30 mg Lisinopril tablets, 100 count and 500 count bottles.
  • Manufacturer: Wockhardt Ltd.
  • Reason: CGMP Deviations. Manufacturer didn’t provide adequate investigation of customer complaints.
  • 69,297 bottles recalled.
  • Lot # DM11003, DM11094, DM11689, DM11873, DM11874, DM12402, DM12412, DM13440, DN10689, DN10693, DM11095, DM11688, DM11860, DM12413, DN10692.

7/17/2015 Lisinopril Recall, Class II

  • Recall issued 4/22/15.
  • 20 mg Lisinopril tablets, 100, 500, and 1000 count bottles.
  • Manufacturer: Wockhardt Ltd.
  • Reason: CGMP Deviations. Manufacturer didn’t provide adequate investigation of customer complaints.
  • 285,381 bottles recalled.
  • Lot numbers: Too many to list. See full recall report here.

7/17/2015 Lisinopril Recall, Class II

  • Recall issued 4/22/15.
  • 10 mg Lisinopril tablets, 100, 500, and 1000 count bottles.
  • Manufacturer: Wockhardt Ltd.
  • Reason: CGMP Deviations. Manufacturer didn’t provide adequate investigation of customer complaints.
  • 278,284 bottles recalled.
  • Lot numbers: Too many to list. See full recall report here.

7/17/2015 Lisinopril Recall, Class II

  • Recall issued 4/22/15.
  • 5 mg Lisinopril tablets, 100, 500, and 1000 count bottles.
  • Manufacturer: Wockhardt Ltd.
  • Reason: CGMP Deviations. Manufacturer didn’t provide adequate investigation of customer complaints.
  • 216,190 bottles recalled.
  • Lot #: DM10991, DM11226, DM11665, DM11810, DM12702, DN10719, DM11651, DM11652, DM11664, DM12701, DN10139, DM11041, DM11267, DM11268, DM11279, DM11286, DM11292, DM11625, DM11626, DM11670, DM11772, DM11773, DM11809, DM12698, DN10110, DN10608, DN10642, DN10694, DN10744, DN10799, DN10839.

Via: NIH.gov

7/8/2015 Lisinopril Recall, Class II

  • Recall issued 6/1/15.
  • 40 mg Lisinopril tablets, 10 count blisters with 10 blister packs per carton.
  • Manufacturer: Wockhardt Ltd.
  • Reason: CGMP Deviations. Manufacturer didn’t provide adequate investigation of customer complaints.
  • 1,516 cartons recalled.
  • Lot# 131935.

7/8/2015 Lisinopril Recall, Class II

  • Recall issued 6/1/15.
  • 20 mg Lisinopril tablets, 10 count blisters with 10 blister packs per carton.
  • Manufacturer: Wockhardt Ltd.
  • Reason: CGMP Deviations. Manufacturer didn’t provide adequate investigation of customer complaints.
  • 5,591 cartons recalled.
  • Lot# 131934.

7/8/2015 Lisinopril Recall, Class II

  • Recall issued 6/1/15.
  • 10 mg Lisinopril tablets, 10 count blisters with 10 blister packs per carton.
  • Manufacturer: Wockhardt Ltd.
  • Reason: CGMP Deviations. Manufacturer didn’t provide adequate investigation of customer complaints.
  • 13,532 cartons recalled.
  • Lot# 131933.

7/8/2015 Lisinopril Recall, Class II

  • Recall issued 6/1/15.
  • 5 mg Lisinopril tablets, 10 count blisters with 10 blister packs per carton.
  • Manufacturer: Wockhardt Ltd.
  • Reason: CGMP Deviations. Manufacturer didn’t provide adequate investigation of customer complaints.
  • 4,718 cartons recalled.
  • Lot# 131928.

7/17/2015 Lisinopril Recall, Class II

  • Recall issued 4/22/15.
  • 2.5 mg Lisinopril tablets, 100 count, 500 count bottles.
  • Manufacturer: Wockhardt Ltd.
  • Reason: CGMP Deviations. Manufacturer didn’t provide adequate investigation of customer complaints.
  • 184,936 cartons recalled.
  • Lot # DM10573, DM11531, DM11532, DM11676, DM11677, DM12543, DM13333, DN10272, DN10405, DN10446, DM11122, DM11130, DM11533, DM11674, DM11675, DM12497, DM13336, DN10289, DN10445, DN10816, DN10817, DN10976.

4/20/2015 Lisinopril Recall, Class II

  • Recall issued 11/14/14, terminated 10/7/15.
  • Lisinopril active ingredient in bags or drums.
  • Manufacturer: Attix Pharmaceuticals.
  • Reason: Possible penicillin cross-contamination.
  • All lots repackaged/distributed 01/05/12 to 02/12/15.

1/16/2014 Lisinopril Recall, Class II

  • Recall issued 7/2/13, terminated 2/7/14.
  • 2.5 mg Lisinopril tablet.
  • Distributor: AidaPak Service.
  • Reason: Label Mixup. May be mislabeled as RANOLAZINE ER or DOCUSATE SODIUM.
  • 300 tablets recalled.
  • Pedigree: AD25264_4, W003365.

8/8/2013 Lisinopril Recall, Class II

  • Recall issued 7/30/13, terminated 6/3/14.
  • 2.5 mg Lisinopril tablets, 100 and 1000 count bottles.
  • Manufacturer: West-ward Pharmaceutical Corp.
  • Reason: Failed Impurities/Degradation specs.
  • 51,704 bottles recalled.
  • Lot # 68679A, 68679C, 64456A, 68980A, 69234A, 69235A, 69607A, 69609C, 69835A, 64455B, 64456C, 64457A, 68679B, 68680A, 68980B, 69607B, 69608A, 69609B, 64455A, 64455C, 64455D, 64456B, 64457B, 68680B, 68980C, 68981A, 69608B, 69609A, 70169A.

7/11/2013 Lisinopril Recall, Class II

  • Recall issued 5/29/13.
  • 20 mg Lisinopril injection.
  • Compounded by: Olympia Pharmacy in Orlando, FL.
  • Reason: Lack of Assurance for Sterility based on FDA inspection
  • 1 item recalled.

5/30/2013 Lisinopril Recall, Class III

  • Recall issued 4/9/13, terminated 1/23/14.
  • 30 mg Lisinopril tablets, 100 count bottles.
  • Manufacturer: Aurobindo Pharma Ltd.
  • Reason: Label Error. Incorrect strength on side of label.
  • 1,776 bottles recalled.
  • Lot # KP3012001-A, KP3012002-A

4/22/2013 Lisinopril Recall, Class III

  • Recall issued 2/26/13, terminated 12/5/13.
  • 10 mg Lisinopril tablets, 1000 count bottles.
  • Manufacturer: Mylan Pharmaceuticals.
  • Reason: Tablets Imprinted With Incorrect ID.
  • 2,405 bottles recalled.
  • Lot #  3002450.

4/7/2013 Lisinopril and Hydrochlorothiazide Recall, Class II

  • Recall issued 3/11/13, terminated 9/3/13.
  • 20 mg and 25 mg Lisinopril and Hydrochlorothiazide tablets, 100 count bottles.
  • Manufacturer/distributor: GSMS.
  • Reason: Presence of Foreign Substance. Steel particles in tablets.
  • 6,158 bottles recalled.
  • Lot # 60429-046-10, 69393A1, 60429-046-1, 0 69395A1, 60429-046-10, 69495A1, 60429-046-10, 69496A1, 60429-046-01, 69497A1, 60429-046-10 69524A1, 60429-046-10, 69524A2, 60429-046-10, 69525A1, 60429-046-10, 69525A2.

1/18/2013 Lisinopril and Hydrochlorothiazide Recall, Class II

  • Recall issued 11/30/12, terminated 7/9/14.
  • 20 mg and 25 mg Lisinopril tablets, 100 and 1000 count bottles.
  • Manufacturer: West-ward Pharmaceutical Corp.
  • Reason: Presence of Foreign Substance. Steel particles in tablets.
  • 43,478 bottles recalled.
  • Lot #: 69392A, 69393A, 69394A, 69395A, 69396A, 69397A , 69495A, 69496A, 69497A, 69498A, 69524A, 69525A.

1/18/2013 Lisinopril Recall, Class II

  • Recall issued 12/7/2012, terminated 8/4/14.
  • 40 mg Lisinopril tablets, 100 and 1000 count bottles.
  • Manufacturer: West-ward Pharmaceutical Corp.
  • Reason: Presence of Foreign Substance. Food grade lubricant and stainless steel in tablets.
  • 32,550 bottles recalled.
  • Lot # 69545A, 69546A, 69546B, 69547A, 69995A, 69999A, 69999B, 70000A, 70001A, 70002A, 70002B, 70003A, 70004A, 69548A, 69549A, 69877A

Also see our page on Levothyroxine recalls here.

Conclusion

The list above simplifies the six major Lisinopril recalls as of 6/5/17, encompassing 29 recalls total. The biggest (multiple) recall from 2015 affected Wockhardt Pharmaceuticals. The next biggest FDA recall of the drug was 2012’s West-Ward Pharmaceutical Corp. recall, affecting over 125,000 bottles. The only other recall over 100,000 bottles was 2016’s Lupin Pharmaceuticals recall, which covered approximately 110,000 bottles.

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Disclosure: The images in this article come from NIH.gov archives and are not necessarily from recalled products.