Class II · Moderate risk
Metformin Hydrochloride Extended - Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Is Metformin recalled?
Yes — there is an active recall. 23 ongoing FDA recalls mention Metformin (91 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Metformin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Metformin recalls on record
none so far in 2026; 91 on record, newest first
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Class III · Low risk
Pioglitazone and Metformin Hydrochloride Tablets
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Class II · Moderate risk
Actoplus met XR
Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Class II · Moderate risk
Synjardy (empagliflozin and metformin hydrochloride)
Cross Contamination With Other Products:
Class II · Moderate risk
PIO&METFORMIN 15/1000 mg Tab 1
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets 1000 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets 1000 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Fortamet (metformin HCl)
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Class III · Low risk
Riomet (metformin hydrochloride oral solution)
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Class III · Low risk
Metformin Hydrochloride Tablets
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
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