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 Ongoing Jun 12, 2026
Reason CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been…
Class II · Moderate risk Ongoing Mar 13, 2025
Reason CGMP Deviations
Class II · Moderate risk Ongoing Feb 25, 2025
Reason Presence of Foreign Tablets/Capsules.
Class II · Moderate risk Terminated Dec 30, 2024
Reason 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 Terminated Feb 22, 2023
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated Mar 31, 2022
Reason Presence of foreign substance: Presence of stainless steel particulates in tablets.
Class II · Moderate risk Terminated Dec 30, 2021
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated Dec 27, 2021
Reason CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated Jun 1, 2021
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated May 4, 2021
Reason Presence of foreign substance: identified as activated carbon.
Class II · Moderate risk Ongoing Apr 28, 2021
Reason CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Class II · Moderate risk Terminated Mar 31, 2021
Reason Microbial Contamination of Non-Sterile Product
Class III · Low risk Terminated Mar 25, 2021
Reason Failed Moisture Limits: Out of specification for water content
Class II · Moderate risk Terminated Mar 15, 2021
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated Mar 15, 2021
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated Mar 15, 2021
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated Mar 15, 2021
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated Mar 15, 2021
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated Mar 15, 2021
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Ongoing Jan 25, 2021
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Class II · Moderate risk Ongoing Jan 4, 2021
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated Nov 1, 2020
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Ongoing Oct 23, 2020
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing Oct 23, 2020
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated Oct 12, 2020
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)