Metformin Hydrochloride Extended-Release (Denton Pharma) - 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) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131
Brand
Denton Pharma, Inc.
Lot Codes / Batch Numbers
a) 30 count: N107051905, exp 10/31/2020, N107052002, N107052005, exp 9/30/2021 b) 60 count: N107051907, exp 10/31/2020, N107052001 6/30/2021, N107052010, N107052008, N107052004, exp 9/30/2021, c) 90 count: C107051908, exp 10/31/2020, C107052002, C107051909 exp 6/30/2021, C107052001, exp 12/31/2020, C107052004, N107052006, N107052007, N107052009, N107052011, N107052012 exp 9/30/2021, d) 120 count: C107051907, N107051904, N107051906 exp 10/31/2020 C107051910, exp 6/30/2021, C107052003, C107052005, N107052003 exp 9/30/2021
Products Sold
a) 30 count: N107051905, exp 10/31/2020; N107052002, N107052005, exp 9/30/2021 b) 60 count: N107051907, exp 10/31/2020; N107052001 6/30/2021; N107052010, N107052008, N107052004, exp 9/30/2021; c) 90 count: C107051908, exp 10/31/2020, C107052002, C107051909 exp 6/30/2021, C107052001, exp 12/31/2020, C107052004, N107052006, N107052007, N107052009, N107052011, N107052012 exp 9/30/2021; d) 120 count: C107051907, N107051904, N107051906 exp 10/31/2020 C107051910, exp 6/30/2021; C107052003, C107052005, N107052003 exp 9/30/2021
Denton Pharma, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 due to CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer). 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: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
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