FDA Drug recall D-0990-2019
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…
- FDA Drug
- Class III
- terminated
- Published 2019-03-20
On 2019-03-20 the FDA classified a Class III recall of 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… by Avkare, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0990-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-03-01 |
| Published | 2019-03-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
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
Failed Dissolution Specifications
Identifiers
| ndc | 42291-633-01 |
|---|---|
| ndc | 42291-633-50 |
| ndc | 42291-634-01 |
| ndc | 42291-634-50 |
| ndc | 42291-635-01 |
| code_info | Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Avkare
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FDA Drug · Class II · 2026-03-04 · Avkare - Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478
FDA Drug · Class II · 2026-01-14 · Avkare - Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister c…
FDA Drug · Class II · 2025-10-15 · Avkare - chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 3847…
FDA Drug · Class II · 2025-09-17 · Avkare - chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 384…
FDA Drug · Class II · 2025-09-17 · Avkare
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0990-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.