Cevimeline Hydrochloride Capsules — Class II drug recall D-1814-2015
Terminated recall by Apotex Inc., reported 2015-09-23, distributed nationwide. Failed Stability Specifications: product may not meet specification limit for assay test.
| Recall number | D-1814-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., Toronto, Canada |
| Recall initiated | 2015-08-17 |
| Classified | 2015-09-15 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2022-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 117,644 bottles |
| Reason classes | potency, specification failure |
| NDC | 60505-3145-01, 60505-3145-05 |
| Expiration dates | 2015-09, 2015-11, 2015-12, 2016-01, 2016-04 |
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
Reason for recall
Failed Stability Specifications: product may not meet specification limit for assay test.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1814-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.