Mesalamine Delayed-Release Tablets — Class II drug recall D-0070-2021
Terminated recall by AVKARE Inc., reported 2020-11-18, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0070-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2020-10-30 |
| Classified | 2020-11-06 |
| Reported by FDA | 2020-11-18 |
| Terminated | 2023-06-02 |
| Distributed | Nationwide (US) |
| Quantity | 15,678 bottles |
| Reason classes | specification failure |
| NDC | 42291-0564-12 |
| Lot numbers | 26085, 26426, 26983, 28647 |
| Expiration dates | 2021-07, 2022-01, 2022-04, 2022-06 |
Product
Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12
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-0070-2021. 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.