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Class II · ModerateActive recall

amneal Metformin Hydrochloride Extended-Release Tablets

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberHF06618A 6/30/2020 HF06718A 6/30/2020
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forAmneal Pharmaceuticals LLC Bridgewater, NJ 08807
NDC53746-0178-05
Show the full FDA record
Full product labelamneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05
Recalling firmAmneal Pharmaceuticals of New York, LLC
DistributionNationwide
QuantityN/A
Recall initiated2020-05-29
Report date2020-07-01
Recall completed—
Recall numberD-1351-2020
ClassificationClass II
FDA statusOngoing
Origin on fileBrookhaven NY United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.