Class II · Moderate risk Terminated
Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC…
Reason Microbial Contamination of Non-Sterile Products
Is Metformin recalled?
91 FDA recalls mention Metformin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Metformin.
Class II · Moderate risk Terminated
Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013…
Reason Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Class III · Low risk Terminated
Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured…
Reason Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place…
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL…
Reason Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Class II · Moderate risk Terminated
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage…
Reason Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class II · Moderate risk Terminated
Metformin HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS…
Reason CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Class II · Moderate risk Terminated
Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu…
Reason Defective container: Product distributed without inner seal on bottles.
Class II · Moderate risk Terminated
Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu…
Reason Defective container: Product distributed without inner seal on bottles.
Class II · Moderate risk Terminated
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd…
Reason Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Class II · Moderate risk Terminated
Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum…
Reason CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.
Class II · Moderate risk Terminated
metFORMIN HCl Tablet 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155010201
Reason Labeling: Label Mixup; metFORMIN HCl Tablet, 500 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921…
Class II · Moderate risk Terminated
Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 7 Tablets per Carton, 5…
Reason Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the…
Class II · Moderate risk Terminated
Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6 Tablets per Carton, 2.5…
Reason Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the…
Class II · Moderate risk Terminated
Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD…
Reason Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The…
Class I · High risk Terminated
metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical…
Reason Labeling: Label Mix up; product labeled did not indicated Extended Release
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