Metformin Extended-Release 750mg (Time-Cap Labs) – 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
Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01
Brand
Marksans Pharma Limited
Lot Codes / Batch Numbers
M125E Oct-20, D001F, C084F Nov-20, F073F, E063F Jan-21, F072F Mar-21, J002F, J087F Apr-21, K080F, L056F Jun 21, M046F, Jul-21, 9R9001, Oct-21, 9R9002, Nov-21, 9R0001, 9R0002 Dec-21, 9R0003, XR0016, 9R0004, 9R0005 Mar-22, 9R0006, 9R0007 Apr-22
Products Sold
M125E Oct-20; D001F, C084F Nov-20; F073F, E063F Jan-21; F072F Mar-21; J002F, J087F Apr-21; K080F, L056F Jun 21; M046F, Jul-21; 9R9001, Oct-21; 9R9002, Nov-21; 9R0001, 9R0002 Dec-21; 9R0003, XR0016, 9R0004, 9R0005 Mar-22; 9R0006, 9R0007 Apr-22
Marksans Pharma Limited is recalling Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, due to CGMP Deviations: detection of 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: detection of 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