Metformin is a first-line medication for type 2 diabetes. We track every FDA enforcement recall involving Metformin (Glucophage) — 43 recalls in our database, including 7 active.
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Glenmark Pharmaceuticals Inc., USA — CGMP Deviations
Recall D-0328-2025
A-S Medication Solutions LLC — Presence of Foreign Tablets/Capsules.
Recall D-0292-2025
Granules Pharmaceuticals Inc. — Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Recall D-0192-2025
MERCK SHARP & DOHME CORP — Presence of foreign substance: Presence of stainless steel particulates in tablets.
Recall D-0746-2022
VIONA PHARMACEUTICALS INC — CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Recall D-0392-2022
VIONA PHARMACEUTICALS INC — CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Recall D-0640-2021
SUN PHARMACEUTICAL INDUSTRIES INC — Presence of foreign substance: identified as activated carbon.
Recall D-0372-2021
SUN PHARMACEUTICAL INDUSTRIES INC — Microbial Contamination of Non-Sterile Product
Recall D-0334-2021
Showing 8 of 43. See all Metformin recalls.
This page is for information only and isn’t medical advice. Always follow your clinician’s guidance.
The FDA publishes recalls, but most never make the news. The reliable way is an automated alert: sign up free and we’ll email you when a Metformin recall is issued.
Most prescriptions filled in the US are generics, so most recalls involve generic products. A recall doesn’t mean the drug itself is unsafe — it usually affects specific lots or manufacturers.
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