Metformin Extended-Release 500mg (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 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) 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 49483-623-50
Brand
Marksans Pharma Limited
Lot Codes / Batch Numbers
a) 90 count: E072F, E074F, E076F Oct-20, D096F, H029F, H031F, XP8276, XP8289 Nov-20, L007F, J022F, H039F, Dec-20, J092F Jan-21, L055F Jun-21, K079F Jul-21, A002G, A003G, A007G Aug-21, A49001 Nov-21, A40001, A40003, A40005 Dec-21, A40009 Feb-22, A40010, XP0036, A40013 Mar-22, A40015 Apr-22 b) 100 count: XP8260 Oct-20, XP0010, XP0016 Dec-21, XP0046 Apr-22, c) 500 count: E037F, G011F Oct-20, F001F Nov-20, H041F, L009F Dec-20, K051F Jun-21, A115G, A010G Sep-21, A40006, A40007, A40008 Jan-22, A40011 Mar-22, A40016, A40018 Apr-22, d) 1000 count: D086F Oct-20, G012F Nov-20, L008F Dec-20, K042F Feb-21, M001F Jul-21, A009G Sep-21, A40002, A40004 Dec-21, A40012 Mar-22, A40014, A40017 Apr-22
Products Sold
a) 90 count: E072F, E074F, E076F Oct-20; D096F, H029F, H031F,XP8276, XP8289 Nov-20; L007F, J022F, H039F, Dec-20; J092F Jan-21; L055F Jun-21; K079F Jul-21; A002G, A003G, A007G Aug-21; A49001 Nov-21; A40001, A40003, A40005 Dec-21; A40009 Feb-22; A40010, XP0036, A40013 Mar-22; A40015 Apr-22 b) 100 count: XP8260 Oct-20; XP0010, XP0016 Dec-21; XP0046 Apr-22; c) 500 count: E037F, G011F Oct-20; F001F Nov-20; H041F, L009F Dec-20; K051F Jun-21; A115G, A010G Sep-21; A40006, A40007, A40008 Jan-22; A40011 Mar-22; A40016, A40018 Apr-22; d) 1000 count: D086F Oct-20; G012F Nov-20; L008F Dec-20; K042F Feb-21; M001F Jul-21; A009G Sep-21; A40002, A40004 Dec-21; A40012 Mar-22, A40014, A40017 Apr-22
Marksans Pharma Limited is recalling Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 4 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