Chlorzoxazone Tablets (Glenmark) – CGMP Deviation (2021)
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
Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Brand
Glenmark Pharmaceuticals Inc., USA
Lot Codes / Batch Numbers
Lots: 29200023 Exp. 03/31/2022, 29200025 Exp. 03/31/2022, 29200036 Exp. 06/30/2022, 29200056 Exp. 09/30/2022, 29200070 Exp. 11/30/2022
Products Sold
Lots: 29200023 Exp. 03/31/2022; 29200025 Exp. 03/31/2022; 29200036 Exp. 06/30/2022; 29200056 Exp. 09/30/2022; 29200070 Exp. 11/30/2022
Glenmark Pharmaceuticals Inc., USA is recalling Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pha due to CGMP Deviations. 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
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