Metformin recalls
FDA drug recall list
Extended-release metformin has been recalled for NDMA impurities. Don't stop taking it without talking to your doctor, since uncontrolled blood sugar is also dangerous.
FDA data updated Last synced
- Reports mentioning it
- 91
- Class I (serious)
- 1
- Class II
- 84
- Class III
- 6
Key facts: metformin recalls
- The FDA has published 91 drug enforcement reports mentioning metformin since 2012, as of October 8, 2026.
- 1 of them were Class I, the most serious category, where a product could cause serious health problems or death.
- The most recent was reported on Jul 8, 2026: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets… (Boehringer Ingelheim Pharmaceuticals, Inc.), Class II.
- Source: U.S. Food and Drug Administration enforcement reports via openFDA. See our sources policy.
Latest 87 metformin recalls
- Jul 8, 2026Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets…Drug · Boehringer Ingelheim Pharmaceuticals, Inc.CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.Class II
- Apr 16, 2025Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottleDrug · Glenmark Pharmaceuticals Inc., USACGMP DeviationsClass II
- Apr 2, 2025METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medicati…Drug · A-S Medication Solutions LLCPresence of Foreign Tablets/Capsules.Class II
- Jan 15, 2025Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx O…Drug · 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.Class II
- Mar 15, 2023Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Ma…Drug · Teva Pharmaceuticals USA IncCGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.Class II
- Apr 13, 2022Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, package…Drug · MERCK SHARP & DOHME CORPPresence of foreign substance: Presence of stainless steel particulates in tablets.Class II
- Feb 2, 2022Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles N…Drug · VIONA PHARMACEUTICALS INCCGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.Class II
- Jan 19, 2022Metformin 750 mg Extended Release NDC # 70518-2920-00Drug · RemedyRepack Inc.CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.Class II
- Jun 30, 2021Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Man…Drug · VIONA PHARMACEUTICALS INCCGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.Class II
- Jun 2, 2021xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablet…Drug · Cardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.Class II
- Synjardy (empagliflozin and metformin hydrochloride) Tablets 12
- xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablet…
- Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12
- Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1…
- Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/…
- Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx…
- Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl
- Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only…
- Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle,…
- Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle,…
- Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Siz…
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only
- metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma Cit…
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-30…
- metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30
- Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only…
- Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville,…
- Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repac…
- RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5…
- Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured…
- Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufa…
- Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manuf…
- Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only…
- Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct
- Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only…
- Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only,…
- Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only…
- Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) un…
- Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Siz…
- Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tabl…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablet…
- amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottle…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distribute…
- Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only,…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amn…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bott…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bott…
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01)…
- amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets…
- metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30)
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle,…
- amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Table…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 coun…
- amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Table…
- metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30)
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-53…
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Onl…
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611…
- Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count b…
- Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Ma…
- Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, M…
- Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Man…
- PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Na…
- Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Man…
- Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000…
- Synjardy (empagliflozin and metformin hydrochloride) Tablets
- Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count…
- Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl
- Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufacture…
- Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl
- Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Al…
- Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle,…
- Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Ma…
- Metformin HCl active pharmaceutical ingredient packaged in varying grams or kg in bags…
- GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2
- metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (…
- GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufac…
- Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu C…
- Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Ca…
- Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manuf…
- metFORMIN HCl Tablet 500 mg, Rx only, Distributed by: AidaPak Service, LLC
- Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, proces…
- Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sampl…
- Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sampl…
- Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle,…
Showing the 87 most recent recalls of metformin products. 91 FDA reports mention metformin in total, including as an ingredient in other products. Use the search on the homepage to look up a specific brand or lot number.
Questions about metformin recalls
Is there a metformin recall right now?
There are no new FDA metformin recall reports in the last 90 days as of October 8, 2026. The most recent was “Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets…” from Boehringer Ingelheim Pharmaceuticals, Inc. (Class II), reported Jul 8, 2026. FDA reports can appear weeks after a recall starts, so also check the FDA's official recall notices.
What should I do with a recalled metformin product?
If you have a recalled metformin product, compare the lot number and expiration date with the recall. Don't stop taking a prescription medicine on your own: call your pharmacist or doctor, who can confirm whether your supply is affected and arrange a replacement. In an emergency, call 911 or Poison Control at 1-800-222-1222.
How do I know if my metformin product is part of the recall?
Open the recall in the list on this page and compare the brand, product size, lot or UPC code, and best-by or expiration date with your package. A match on the product name alone doesn't mean your item is affected. You can also search by lot number on the FindMyRecall homepage.
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