Class II · Moderate risk
Synjardy XR Tablets
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.
Is Metformin recalled?
Yes — there is an active recall. 23 ongoing FDA recalls mention Metformin (91 total). Check the affected lots below.
Most common reason: Nitrosamine impurity (47 of these recalls)
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 in 2026
1 initiated in 2026, 91 in total — newest first
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets 1000mg
CGMP Deviations
Class II · Moderate risk
Metformin Hydrochloride Extended- Release 500mg
Presence of Foreign Tablets/Capsules.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
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 · Moderate risk
Metformin hydrochloride Extended-Release Tablets
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Janumet (sitagliptin and metformin HCl)
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Class II · Moderate risk
Metformin 750 mg Extended Release NDC # 70518-2920-00
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Metformin HCl Extended-Release Tablets
Presence of foreign substance: identified as activated carbon.
Class II · Moderate risk
Preferred Pharmaceuticals Inc.
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Class II · Moderate risk
Riomet (metformin hydrochloride oral solution)
Microbial Contamination of Non-Sterile Product
Class III · Low risk
Metformin HCl Extended-Release Tablets
Failed Moisture Limits: Out of specification for water content
Class II · Moderate risk
Synjardy XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Synjardy XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Jentadueto XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Synjardy (empagliflozin and metformin hydrochloride)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
xigduo XR (dapagliflozin/metformin HCl extended-release)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
xigduo XR (dapgliflozin/metformin HCl extended-release)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Metformin HCl Extended Release Tablets USP 500 mg
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Metformin HCL E/R 500 mg
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
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