Oxybutynin Chloride Extended-Release Tablets USP 10 mg — Class III drug recall D-0990-2019
Terminated recall by AVKARE Inc., reported 2019-03-20, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0990-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2019-03-01 |
| Classified | 2019-03-11 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2020-01-14 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 42291-0633, 42291-0633-01, 42291-0633-50, 42291-0634, 42291-0634-01, 42291-0634-50, 42291-0635, 42291-0635-01 |
| Expiration dates | 2020-07 |
Product
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reason for recall
Failed Dissolution Specifications
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-0990-2019. 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.