Metformin Hydrochloride Extended-Release 500mg (Lupin) – 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, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07
Brand
Lupin Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Batch # G808293 Aug-20 G808284 Aug-20 G808285 Aug-20 G808343 Aug-20 G901201 Dec-20 G901202 Dec-20 G906915 Jul-21 G906913 Jul-21 G906914 Jul-21 G002135 Jan-22 G002849 Feb-22
Lupin Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured 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