Posted on June 26, 2017

Metformin is a popular generic, widely used and generally well tolerated for the treatment of type 2 diabetes. Despite being made by dozens of manufacturers around the world, to date there have been only 15 recalls of the popular drug, with most being minor.

The exceptions are a 27,000 kilo recall from Smruthi Organics in early 2014, and a recall of 117,049 sample cartons from Bristol-Myers Squibb in 2012. The next biggest Metformin recall after that came from Actavis Laboratories and affected 13,284 bottles in 2015.

Metformin Recalls

There have been 15 total recalls of Metformin from 2012 through 2017. The Metformin recalls involved a grand total of over 150,000 bottles of the popular diabetes medication. The most recent was a Class II event in late 2016 from Ascend Laboratories.

Several other companies have been the focus of Metformin recalls. Most of the incidents were relatively small, in the sub-7,000 bottles range. The biggest by pill count was a 2012 recall from Bristol-Myers Squibb that affected over 117,000 sample packs.

Metformin Facts

Via: NIH.gov

Metformin is a diabetes medication in oral form that helps manage blood sugar levels. It’s used in cases of type 2 diabetes. It’s sometimes given along with insulin and other medications. It’s not meant for type 1 diabetes.

Serious side effects can include allergic reaction with difficulty breathing or facial swelling, and dangerous or even fatal lactic acidosis marked by numbness, fatigue, slow heart rate, and vomiting. More common side effects are nausea, upset stomach, vomiting, and diarrhea.

Major Metformin Recalls

There have been three major Metformin recalls and several minor ones. The biggest in terms of bottles/cartons was a 2012 recall by Bristol-Myers Squibb company involving over 117,000 sample cartons. In that case, the outer label of the sample packs was mislabeled with the wrong dosage information.

The biggest Metformin recall by volume happened in 2013 at Smruthi Organics in India, when 27,000 kilos of the popular drug in over 1,000 barrels was found to be manufactured out of accordance with Good Manufacturing Practices.

The next largest Metformin recall in 2015 involved 13,284 bottles made by Actavis Laboratories in Florida. The drug in the tablets had failed to meet specifications.

  • 2015 Metformin recall: Approx. 13,000 bottles, Actavis Laboratories.
  • 2013 Metformin recall: Approx. 27,000 kilos, Smruthi Organics.
  • 2012 Metformin recall: Approx. 117,000 sample cartons, Bristol-Myers Squibb Company.

Metformin Manufacturers

Via: NIH.gov

Metformin was originally discovered in 1922. It’s been a widely used generic for decades, so it’s made by dozens of different pharmaceutical manufacturers worldwide. The short list below shares a few of the makers of Metformin.

  • Sandoz
  • Apotex
  • Mylan
  • Mallinckrodt
  • Teva Pharmaceuticals
  • Alkem
  • Dr. Reddy’s Laboratories
  • Atlas Pharmaceuticals
  • Sun Pharmaceutical Industries
  • Torrent Pharmaceuticals

Full List of All Metformin Recalls

The list below shows all 15 Metformin recall orders from 2012 through 2017. Most of them were minor in terms of the number of bottles affected, falling under the 7,000 mark. Almost all were Class II, with a risk of serious (but not imminent) injury or death.

Class I, II, and III Recalls

The FDA enforces three different drug recall classes. For reference, we’ve defined them all here.

Class I Recall. This is an urgent recall with significant and immediate risk of death or severe injury. It’s very rare, though one Metformin recall issued in 2011 was classified as Class I in 2014. That recall, from Shamrock Medical Solutions Group, happened when the label failed to disclose that the drug had an extended time release.

Class II Recall. This recall type also has a serious risk of injury or death, though it’s not imminent. Most of the Metformin recalls below are Class II.

Class III Recall. This is the least serious FDA recall. It mostly concerns non-life-threatening FDA violations. Only one of the recalls below is Class III. It affected 5,346 bottles with incorrect package inserts from Janssen Ortho.

Recall Dates Shown Below

We’ve listed all recalls below in reverse chronological order, by the date they were classified by the FDA. In most cases, the recalls were issued months or sometimes years before their classification dates. All original issue dates are shown in the first bullet point for each Metformin recall.

11/29/2016 Metformin Recall, Class II

  • Recall issued 11/2/2016.
  • 500 mg Metformin Hydrochloride tablets, USP, 1,000 tablets.
  • Manufacturer: Alkem Laboratories Ltd.
  • Reason: Amlodipine tablets were found inside a Metformin Hydrochloride bottle.
  • 1,739 bottles recalled.
  • Lot # 6121056.
Via: NIH.gov

10/25/2016 Metformin Recall, Class III

  • Recall issued 10/19/2016.
  • 150 mg/ 1,000 mg Canagliflozin/Metformin HCl (Invokamet) tablets, 60-count bottle.
  • Manufacturer: Janssen Ortho, LLC.
  • Reason: Incorrect label.
  • 5,346 bottles recalled.
  • Lot # 16GG581X.

10/13/2015 Metformin Recall, Class II

  • Recall issued 9/25/2015, terminated 4/10/2017.
  • 1,000 mg Metformin Hydrochloride ER tablets, 60-count bottle.
  • Manufacturer: Actavis Laboratories FL, Inc.
  • Reason: Failed specs.
  • 13,284 bottles recalled.
  • Lot # 1037736A.

4/20/2015 Metformin Recall, Class II

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

4/7/2015 Metformin Recall, Class II

  • Recall issued 3/25/2015.
  • 2.5 mg/500 mg Glipizide and Metformin HCl tablets, USP, 100-count bottles.
  • Manufacturer: Heritage Pharmaceuticals Inc.
  • Reason: Failed specs. Unknown impurity.
  • 6,816 bottles recalled.
  • Lot # 18020994, 18021311.

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7/23/2014 Metformin Recall, Class I

  • Recall issued 9/27/2011, terminated 7/31/2014.
  • 500 mg Metformin ER tablets.
  • Repackaged by: Shamrock Medical Solutions.
  • Reason: Labeling: Failed to indicate that the drug had an extended release.
  • 88/5 mg tablets recalled.
  • Lot # 00267J.

5/12/2014 Metformin Recall, Class II

  • Recall issued 3/24/2014, terminated 11/14/2014.
  • 5 mg/ 500 mg Glyburide and Metformin HCl tablets, USP, 500-count bottle.
  • Manufacturer: Emcure Pharmaceuticals Ltd.
  • Reason: CGMP Deviations. Lab testing requirements not followed.
  • 2,532 bottles recalled.
  • TE36018.
Via: NIH.gov

5/5/2014 Metformin Recall, Class II

  • Recall issued 3/13/2014, terminated 6/10/2015.
  • 500 mg Metformin Hydrochloride tablets, USP, 500 tablets.
  • Manufacturer: Blu Caribe Dorado.
  • Reason: Defective container. No inner seal.
  • 14,000 tablets recalled.
  • Lot # 13E0008F3P8V.

5/5/2014 Metformin Recall, Class II

  • Recall issued 3/13/2014, terminated 6/10/2015.
  • 1,000 mg Metformin Hydrochloride tablets, USP, 500 tablets.
  • Manufacturer: Blu Caribe Dorado.
  • Reason: Defective container. No inner seal.
  • 101,500 tablets recalled.
  • Lot # 13E0014F1P8V.

2/26/2014 Metformin Recall, Class II

  • Recall issued 1/28/2014, terminated 9/29/2014.
  • 500 mg Metformin HCl ER tablets, USP, 500-count bottles.
  • Manufacturer: Sun Pharmaceutical Inc., Ltd.
  • Reason: Foreign tablets. Complaints of Gabapentin tablets in a bottle of Metformin.
  • 2,528 bottles recalled.
  • Batch JKM2433A.

1/16/2014 Metformin Recall, Class II

  • Recall issued 7/2/2013, terminated 2/7/2014.
  • 500 mg Metformin HCl tablet.
  • Distributed by: AidaPak Service.
  • Reason: Label Mixup: Possibly mislabeled as Omega-3 Fatty Acid.
  • 100 Tablets recalled.
  • Pedigree: AD46312_25.

1/10/2014 Metformin Recall, Class II

  • Recall issued 10/7/2013.
  • Metformin Hydrochloride USP, 25 kg drum.
  • Manufacturer: Smruthi Organics Limited.
  • Reason: CGMP Deviations: Active ingredient not manufactured per Good Manufacturing Practices.
  • 27,000 kg recalled.
  • Lot # DMFH-366/11, DMFH-367/11, DMFH-368/11, DMFH-369/11, DMFH-370/11, DMFH-371/11, DMFH-372/11, DMFH-373/11, DMFH-374/11, DMFH-375/11, DMFH-376/11, DMFH-393/11, DMFH-394/11, DMFH-395/11, DMFH-396/11, DMFH-397/11, DMFH-399/11, DMFH-400/11, DMFH-401/11, DMFH-402/11, DMFH-403/11, DMFH-404/11, DMFH-405/11, DMFH-406/11.

10/24/2012 Metformin Recall, Class II

  • Recall issued 6/5/2012, terminated 7/10/2013.
  • 2.5 mg/ 1,000 mg Kombiglyze XR (Saxagliptin and Metformin HCl ER) tablets (sample only), 6 tablets per carton.
  • Manufacturer: Bristol-Myers Squibb Company.
  • Reason: Incorrect label. Some cartons labeled incorrectly as Kombiglyze XR 2.5mg/1000mg.
  • 117,049 sample cartons recalled.
  • Lot # 1J6024PA , 1J6025PA, 1K6049PA, 1L9015WA.

10/24/2012 Metformin Recall, Class II

  • Recall issued 6/5/2012, terminated 7/10/2013.
  • 5 mg/ 500 mg Kombiglyze XR (Saxagliptin and Metformin HCl ER) tablets (sample only), 7 tablets per carton.
  • Manufacturer: Bristol-Myers Squibb Company.
  • Reason: Incorrect label. Some cartons labeled incorrectly as Kombiglyze XR 2.5mg/1000mg.
  • Lot # 1J6024PA, 1J6025PA, 1K6049PA, 1L9015WA.

7/27/2012 Metformin Recall, Class II

  • Recall issued 3/14/2012, terminated 12/17/2013.
  • 1,000 mg Metformin HCl tablets, USP, 1,000-count bottle.
  • Manufacturer: Cadila Healthcare Ltd.
  • Reason: Foreign substance. Complaint of brown specks in tablets.
  • 1,176 bottles recalled.
  • Lot # ML9605.

Conclusion

There have been 15 total Metformin recalls from 2012 through 2017. Three of those were relatively major, though none reached into the millions of pills as with some other popular generics like Lisinopril. The biggest recall by volume happened in 2014, when an Indian firm failed to follow Good Manufacturing Practices with 27,000 kilos of the drug in over 1,000 barrels.

Disclosure: the images in this article are for illustration only and don’t necessarily reflect images of recalled Metformin.

 

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