Mesalamine Delayed-Release Tablets — Class II drug recall D-0069-2021
Terminated recall by Teva Pharmaceuticals USA, reported 2020-11-18, distributed nationwide. Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability tes
| Recall number | D-0069-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2020-10-28 |
| Classified | 2020-11-06 |
| Reported by FDA | 2020-11-18 |
| Terminated | 2021-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 133,829 bottles |
| Reason classes | specification failure |
| NDC | 00591-2245, 00591-2245-22 |
| Lot numbers | 1342498A, 1342499A, 1354638A, 1354639A, 1358274A, 1358448A, 1364618A, 1366195A, 1369884A, 1369885A, 1373570A, 1373571A, 1388571A, 1395725A, 1396585A, 1397550A, 1399389A, 1403885A, 1403886A |
| Expiration dates | 2020-12, 2021-01, 2021-03, 2021-05, 2021-06, 2021-07, 2022-01, 2022-04, 2022-06 |
Product
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.
Reason for recall
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
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-0069-2021. 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.