Cevimeline Capsules (Apotex) – Stability Test Failure (2015)
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
Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5
Brand
Apotex Inc.
Lot Codes / Batch Numbers
Lot #s: a) KP9749, KT3501, Exp 09/2015, KP4524, Exp 11/2015, KV8264, Exp 01/2016, KX8713, KX8714, KX8715, Exp 04/2016, b) KP4525, Exp 11/2015, KP9750, Exp 12/2015, KX8716, Exp 04/2016
Products Sold
Lot #s: a) KP9749, KT3501, Exp 09/2015, KP4524, Exp 11/2015, KV8264, Exp 01/2016, KX8713, KX8714, KX8715, Exp 04/2016; b) KP4525, Exp 11/2015, KP9750, Exp 12/2015, KX8716, Exp 04/2016
Apotex Inc. is recalling Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Man due to Failed Stability Specifications: product may not meet specification limit for assay test.. 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
Failed Stability Specifications: product may not meet specification limit for assay test.
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