Class II · Moderate risk
Riomet (metformin hydrochloride)
Microbial Contamination of Non-Sterile Products
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
Metformin Hydrochloride Tablets
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Class III · Low risk
Invokamet (canagliflozin and metformin HCl)
Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Class II · Moderate risk
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class II · Moderate risk
Metformin HCl active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Class II · Moderate risk
Metformin Hydrochloride Tablets USP 1000 mg
Defective container: Product distributed without inner seal on bottles.
Class II · Moderate risk
Metformin Hydrochloride Tablets USP 500 mg
Defective container: Product distributed without inner seal on bottles.
Class II · Moderate risk
Metformin HCl Extended-Release Tablets
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Class II · Moderate risk
Metformin Hydrochloride USP
CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.
Class II · Moderate risk
metFORMIN HCl Tablet 500 mg
Labeling: Label Mixup; metFORMIN HCl Tablet, 500 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD32742_1, EXP: 5/1/2014.
Class II · Moderate risk
Kombiglyze XR
Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.
Class II · Moderate risk
Kombiglyze XR
Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.
Class II · Moderate risk
Metformin Hydrochloride Tablets
Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.
Class I · High risk
metFORMIN ER Tablets
Labeling: Label Mix up; product labeled did not indicated Extended Release
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