Metformin Hydrochloride Extended-Release (Teva) – NDMA Impurity (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Brand
Teva Pharmaceuticals USA
Lot Codes / Batch Numbers
a) 1329548A, exp. date 06/2020 1338302M, exp. date 10/2020 1348968M, exp. date 10/2020 1348969M, exp. date 10/2020 1348970M, exp. date 11/2020 1376339M, exp. date 09/2021 b) 1323460M, exp. date 06/2020 1330919M, exp. date 6/2020 1338300A, exp. date 10/2020 1341135M, exp. date 12/2020 1391828M, exp. date 11/2021
Products Sold
a) 1329548A, exp. date 06/2020 1338302M, exp. date 10/2020 1348968M, exp. date 10/2020 1348969M, exp. date 10/2020 1348970M, exp. date 11/2020 1376339M,, exp. date 09/2021 b) 1323460M, exp. date 06/2020 1330919M, exp. date 6/2020 1338300A, exp. date 10/2020 1341135M, exp. date 12/2020 1391828M, exp. date 11/2021
Teva Pharmaceuticals USA is recalling Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1, due to CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026