Posted on June 15, 2017

This article gives details for all 33 recalls of Atorvastatin since it went generic in 2012, paying special attention to the four major recalls involving 50,000 to 2.4 million bottles each.

Atorvastatin, the generic form of Lipitor, is actually Atorvastatin Calcium, but for simplicity’s sake, it’s most often referred to simply as Atorvastatin. One of the statin drugs, it’s primary use is limiting the body’s production of cholesterol.

The most recent recall of this drug was issued on 3/20/2017. A Class II recall affecting Atorvastatin from Mylan Pharmaceuticals, it spanned four separate recall orders issued on the same day. All together, the major 2017 action recalled over 2.4 million bottles of the popular generic form of Lipitor.

Atorvastatin Recalls

There have been 33 total recalls of Atorvastatin from 2012 through 2017. The recalls were either mandated by the FDA or issued voluntarily by the manufacturer.

Four of the recalls were very large, involving 50,000 to 2.4 million bottles each.

The businesses involved in the four major recalls were Mylan Pharmaceuticals, Ranbaxy, and Dr. Reddy’s Laboratories. Smaller recalls originated from Aidapak services, Golden State Medical Supply, and Physicians Total Care.

The smallest recall from Physicians Total Care involved only three bottles. That recall started when complaints of an “uncharacteristic odor” led to the discovery of foreign chemicals in the tablets. The biggest was the 2017 Mylan Pharmaceuticals recall, affecting over 2.4 million bottles. That recall stemmed from microbial contamination.

Atorvastatin Facts

Via: NIH.gov

Atorvastatin is a generic form of the popular drug Lipitor. It’s a statin drug, also known as an HMG-CoA reductase inhibitor. It works by lowering the body’s production of cholesterol and other fatty substances. First marketed in 1996, the drug entered the generic domain in late 2011.

Serious though not common side effects may include severe allergic reactions, confusion, muscle pain, depression, painful and/or frequent urination, severe back or stomach pain, and liver problems. More common side effects are joint pain, sore throat, and gastrointestinal issues.

Major Atorvastatin Recalls

There have been four major Atorvastatin recalls since the popular statin entered the generic domain in late 2011. The biggest by far is the Mylan Pharmaceuticals recall, issued on March 20th of 2017. The recall happened because of microbial contamination and affected over 2.4 million bottles. It spanned five distinct recall orders for different dosages and bottle sizes.

The next biggest was 2012’s recall from Ranbaxy, Inc. That one involved roughly 500,000 bottles and comprised four separate recall orders. The reason for that recall was small glass particles in the tablets.

The smallest of the big four was the 2015 Atorvastatin recall from Dr. Reddy’s Laboratories. That action consisted of seven distinct recall orders, all issued on the same day, with each one affecting anywhere from 576 bottles to 17,000 bottles. The reason given was a superpotent drug.

Below is the top-level view of the four biggest Atorvastatin recalls to date:

  • 2017 Atorvastatin recall: Approx. 2.4 million bottles, Mylan Pharmaceuticals.
  • 2015 Atorvastatin recall: Approx. 53,000 bottles, Dr. Reddy’s Laboratories.
  • 2015 Atorvastatin recall: Approx 64,000 bottles, Ranbaxy.
  • 2012 Atorvastatin recall: Approx. 500,000 bottles, Ranbaxy.

Atorvastatin Manufacturers

Via: NIH.gov

Atorvastatin is one of the five most popular generics, a status it has held since early 2012. As such, several different manufacturers compete to make and market the hot-selling drug. There’s a partial list here:

  • Ranbaxy
  • Watson Pharmaceuticals
  • Pfizer
  • Dr. Reddy’s Laboratories
  • Apotex
  • Kremers Urban Pharmaceuticals
  • Invagen Pharmaceuticals
  • Mylan Pharmaceuticals
  • Sun Pharmaceuticals
  • Sciegen Pharmaceuticals

Full List of All Atorvastatin Recalls

Here’s the full list of all 33 FDA Atorvastatin recalls to date. It includes multiple discrete recall numbers for the four major recalls. It also gives details on several smaller recalls, affecting a few hundred bottles each.

The Difference Between Class I, II, and III Recalls

The recalls listed below each have their own FDA class number. About half are Class II and the other half Class III. For reference, here are definitions of the three different kinds of FDA recalls.

Class I Recall. The most urgent, with significant and immediate risk of death or severe injury. Very rare. There haven’t been any Class I recalls of Atorvastatin to date.

Class II Recall. Very serious, but risk of death/injury isn’t as severe as with Class I. More than half the recalls below are in this class, including the Mylan and Ranbaxy events.

Class III Recall. Mostly an FDA rules violation that doesn’t risk death or serious injury. Nearly half the recalls shown below are Class II, including the 2015 incident from Dr. Reddy’s Laboratories.

About the Recall Dates Below

The FDA issues each recall on one date, classifies it into one of the three categories above on a different date, and then sometimes terminates the recall on a third date. Below, we’ve listed each recall in order by the classification date, with the most recent recall first. The first bullet point for each item is the issue date.

Via: NIH.gov

3/28/2017 Atorvastatin Recall, Class II

  • Recall issued 3/20/2017.
  • 10 mg Atorvastatin Tablets, 90-count and 500-count bottles.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: Microbial Contamination. Objectionable organisms identified.
  • 1,233,107 bottles recalled.
  • Lot # 3076141, 3076142, 2007223, 2007335, 2007336, 2007446, 3084691, 3084692, 3073773, 2007445, 3076139, 3076140, 3076143, 3076144, 3076145, 2007445, 3070837, 3073773, 3076139, 3073774, 2007445.

3/28/2017 Atorvastatin Recall, Class II

  • Recall issued 3/20/2017.
  • 20 mg Atorvastatin Tablets, 90-count and 500-count bottles.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: Microbial Contamination. Objectionable organisms identified.
  • 299,112 bottles recalled.
  • Lot # 3073776, 3073777, 3074909, 3075564, 3075565, 2007338, 3070838, 3073775, 3074908, 3074909, 3075564, 2007224, 3075887, 2007337, 2007338.

3/28/2017 Atorvastatin Recall, Class II

  • Recall issued 3/20/2017.
  • 40 mg Atorvastatin Tablets, 90-count and 500-count bottles.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: Microbial Contamination. Objectionable organisms identified.
  • 444,201 bottles recalled.
  • Lot # 3073779, 3073780, 3074910, 3075568, 3075889, 3075890, 2007339, 2007340, 3079881, 3079882, 3070839, 3073778, 3073779, 3075566, 3075567, 3075890, 2007225, 2007340, 3079880, 3079881.

3/28/2017 Atorvastatin Recall, Class II

  • Recall issued 3/20/2017.
  • 80 mg Atorvastatin Tablets, 90-count and 500-count bottles.
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Reason: Microbial Contamination. Objectionable organisms identified.
  • 452,269 bottles recalled.
  • Lot # 3073782, 3073783, 3074915, 3074916, 3074917, 3074918, 3075572, 3075573, 3075574, 2007226, 3075894, 2007344, 2007345, 2007346, 2007451, 2007452, 2007453, 2007454, 3070840, 3073781, 3074911, 3074912, 3074913, 3074914, 3075570, 3075571, 3075892, 3075893, 2007341, 2007342, 2007343, 2007347, 2007456.

3/28/2017 Atorvastatin Recall, Class II

  • Recall issued 3/21/2017.
  • 10 mg Atorvastatin Tablets, 100-count Unit Dose Tablets (10 x 10) per carton.
  • Manufacturer: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
  • Reason: Microbial Contamination. Objectionable organisms identified.
  • 1,527 cartons recalled.
  • Lot # 3084288.

3/9/2016 Atorvastatin Recall, Class III

  • Recall issued 1/27/2016.
  • 10 mg Atorvastatin, 10 tablets per blister, 100-count package.
  • Manufacturer: Apotex Inc.
  • Reason: Failed Impurities and Degradation Specs.
  • 222 100-count packages (22,000 tablets) recalled.
  • Lot # GS005602, GS008855, GS009074, GS009393, GS009760, GS010599.

3/9/2016 Atorvastatin Recall, Class III

  • Recall issued 1/27/2016.
  • 20 mg Atorvastatin, 10 tablets per blister, 100-count package.
  • Manufacturer: Apotex Inc.
  • Reason: Failed Impurities and Degradation Specs.
  • 74 100-count packages (7,400 tablets) recalled.
  • Lot # GS008856, GS010268, GS010600.

3/9/2016 Atorvastatin Recall, Class III

  • Recall issued 1/27/2016.
  • 40 mg Atorvastatin, 10 tablets per blister, 100-count package.
  • Manufacturer: Apotex Inc.
  • Reason: Failed Impurities and Degradation Specs.
  • 172 100-count packages (17,200 tablets) recalled.
  • Lot # GS009075, GS009763, GS010178.

3/9/2016 Atorvastatin Recall, Class III

  • Recall issued 1/27/2016.
  • 80 mg Atorvastatin, 10 tablets per blister, 100-count package.
  • Manufacturer: Apotex Inc.
  • Reason: Failed Impurities and Degradation Specs.
  • 168 100-count packages (16,800 tablets) recalled.
  • Lot # GS005603, GS006691, GS009073, GS009395, GS009764.

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8/27/2015 Atorvastatin Recall, Class III

  • Recall issued 8/13/2015.
  • 2.5 mg/ 10 mg Amlodipine besylate and Atorvastatin tablets, 30 Count Bottles.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • 1,056 Bottles recalled.
  • Lot # C403575.

8/27/2015 Atorvastatin Recall, Class III

  • Recall issued 8/13/2015.
  • 2.5 mg/20 mg Amlodipine besylate and Atorvastatin tablets, 30 Count Bottles.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • 576 Bottles recalled.
  • Lot # C403574.
Via: NIH.gov

8/27/2015 Atorvastatin Recall, Class III

  • Recall issued 8/13/2015.
  • 2.5 mg/40 mg Amlodipine besylate and Atorvastatin tablets, 30 Count Bottles.
  • Manufacturer: Dr. Reddy’s Laboratories Limited.
  • Reason: Subpotent drug.
  • 984 Bottles recalled.
  • Lot # C402341.

8/27/2015 Atorvastatin Recall, Class III

  • Recall issued 8/13/2015.
  • 5 mg/20 mg Amlodipine besylate and Atorvastatin 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 Atorvastatin Recall, Class III

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

8/27/2015 Atorvastatin Recall, Class III

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

8/27/2015 Atorvastatin Recall, Class III

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

6/18/2015 Atorvastatin Recall, Class III

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

6/18/2015 Atorvastatin Recall, Class III

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

6/18/2015 Atorvastatin Recall, Class III

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

6/18/2015 Atorvastatin Recall, Class III

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

10/10/2014 Atorvastatin Recall, Class II

  • Recall issued 6/2/2014.
  • 40 mg Atorvastatin tablet.
  • Manufacturer: Apotex Inc.
  • Reason: Valacyclovir tablets were repacked as Atorvastatin.
  • 1,177 packets recalled.
  • Lot # 204751.

2/21/2014 Atorvastatin Recall, Class II

  • Recall issued 1/16/2014.
  • 10 mg Atorvastatin tablets, 90-count tablets per bottle.
  • Manufactured for: Ranbaxy Pharmaceuticals Inc.
  • Reason: Foreign tablets present. A pharmacist reported a 20 mg tablet in a sealed bottle of 10 mg tablets.
  • 64,626 bottles recalled.
  • Lot # 2407255, 2407256.

1/20/2014 Atorvastatin Recall, Class II

  • Recall issued 7/2/2013.
  • 10 mg Atorvastatin tablet.
  • Manufacturer: Distributed by: AidaPak Service, LLC.
  • Reason: Label Mixup. May be mislabeled as Pancrelipase DR, Omeprazole/Sodium Bicarbonate, or Aspirin.
  • 990 Tablets recalled.
  • Pedigree: AD33897_4, AD49582_7, W002774, W003095.

1/20/2014 Atorvastatin Recall, Class II

  • Recall issued 7/2/2013.
  • 20 mg Atorvastatin tablet.
  • Distributor: AidaPak Service, LLC.
  • Reason: Label Mixup. May be mislabeled as Coenzyme Q-10 or 10 mg Atorvastatin.  
  • 811 Tablets recalled.
  • Pedigree: AD33897_7, AD49582_10.

1/20/2014 Atorvastatin Recall, Class II

  • Recall issued 7/2/2013.
  • 40 mg Atorvastatin tablet.
  • Distributor: AidaPak Service, LLC.
  • Reason: Label Mixup. May be mislabeled as 10 mg Atorvastatin or Finasteride.
  • 810 Tablets recalled.
  • Pedigree: AD33897_10, W003096.

1/20/2014 Atorvastatin Recall, Class II

  • Recall issued 7/2/2013.
  • 80 mg Atorvastatin tablet.
  • Distributor: AidaPak Service, LLC.
  • Reason: Label Mixup. May be mislabeled as Omega-3 Fatty Acid, Tacrolimus, or Levothyroxine Sodium.  
  • 270 Tablets recalled.
  • Pedigree: AD73627_1, W003213, AD46300_1.

1/16/2014 Atorvastatin Recall, Class II

  • Recall issued 7/2/2013.
  • 20 mg Atorvastatin tablet.
  • Distributor: AidaPak Service, LLC.
  • Reason:Label Mixup. May be mislabeled as Guaifenesin ER.
  • 90 Tablets recalled.
  • Pedigree: W003846.

1/16/2014 Atorvastatin Recall, Class II

  • Recall issued 7/2/2013.
  • 80 mg Atorvastatin tablet.
  • Distributor: AidaPak Service, LLC.
  • Reason: Label Mixup. May be mislabeled as Lactobacillus GG.
  • 90 Tablets recalled.
  • Pedigree: AD21965_4.

11/29/2012 Atorvastatin Recall, Class II

  • Recall issued 11/9/2012.
  • 10 mg Atorvastatin tablets, 90 tablets per bottle.
  • Manufactured for: Ranbaxy Pharmaceuticals Inc.
  • Reason: May contain glass particles.
  • 120,201 Bottles recalled.
  • Lot # 2436144, 2436582, 2441567, 2441568.

11/29/2012 Atorvastatin Recall, Class II

  • Recall issued 11/9/2012.
  • 20 mg Atorvastatin tablets, 90 tablets per bottle.
  • Manufactured for: Ranbaxy Pharmaceuticals Inc.
  • Reason: May contain glass particles.
  • 203,198 bottles recalled.
  • Lot # 2436731, 2437381, 2437940, 2437942, 2437945, 2437947, 2437952, 2437953, 2437960, 2440676, 2440677, 2440680, 2440681.

11/29/2012 Atorvastatin Recall, Class II

  • Recall issued 11/9/2012.
  • 40 mg Atorvastatin tablets, 90 and 500 tablets per bottle.
  • Manufactured for: Ranbaxy Pharmaceuticals Inc.
  • Reason: May contain glass particles.
  • 157,026 Bottles recalled.
  • Lot # 2434265, 2434266, 2434824, 2434826, 2434827, 2434828, 2434829, 2434830, 2434831, 2436580, 2436725, 2436727, 2436729, 2437377, 2437380, 2437941, 2437943, 2437944, 2437949, 2437950, 2437955, 2437956, 2437957, 2440675.

11/21/2012 Atorvastatin Recall, Class II

  • Recall issued 8/21/2012.
  • 10 mg Atorvastatin tablets, 90-count tablets per bottle.
  • Manufactured for: Ranbaxy Pharmaceuticals Inc.
  • Reason: Pharmacist found foreign tablet (20 mg Atorvastatin) in a sealed bottle of 10 mg tablets.
  • 32,208 bottles recalled.
  • Lot # 2407258.

6/19/2012 Atorvastatin Recall, Class II

  • Recall issued 2/8/2012.
  • 40 mg Lipitor (Atorvastatin), 30 tablets.
  • Repacked and distributed by: Physicians Total Care, Inc.
  • Reason: Complaints of uncharacteristic odor led to discovery of chemical contamination with 2,4,6 tribromoanisole.
  • 3 bottles recalled.
  • Lot # 6284, 60DI, 61AA.

Conclusion

There have been four major recalls of Atorvastatin Calcium since the popular drug went generic in 2012, with 33 recalls total. The affected companies were Mylan Pharmaceuticals with over 2.4 million bottles recalled, Ranbaxy with over half a million bottles, and Dr. Reddy’s Laboratories with just over 50,000.

The biggest recall by far is the ongoing 2017 Mylan recall of 2.4 million bottles.

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