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Class II · ModerateRecall completed

Metformin HCl Extended Release Tablets USP 500 mg

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

Does this affect you?
Check your lot numberE0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022
Where it was soldDistributed to two physician's offices located in FL.
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) levels in excess of the Acceptable Daily Intake Limit.

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 / forPreferred Pharmaceuticals, Inc.
NDC68788-6932-1
Show the full FDA record
Full product labelMetformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.
Recalling firmPreferred Pharmaceuticals, Inc.
DistributionDistributed to two physician's offices located in FL.
Quantity99 bottles (9990 Extended Release Tablets)
Recall initiated2020-11-01
Report date2020-11-25
Recall completed2024-05-20
Recall numberD-0077-2021
ClassificationClass II
FDA statusTerminated
Origin on fileAnaheim CA 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.