Minocycline Hydrochloride Extended-Release Tablets — Class III drug recall D-0827-2020
Terminated recall by Ascend Laboratories LLC, reported 2020-02-12, distributed nationwide. Failed Dissolution Specifications: low out of specification results for dissolution testing.
| Recall number | D-0827-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories LLC, Parsippany, NJ, United States |
| Recall initiated | 2020-01-22 |
| Classified | 2020-02-05 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2021-10-27 |
| Distributed | Nationwide (US) |
| Quantity | 4,728 bottles |
| Reason classes | specification failure |
| NDC | 67877-0436, 67877-0436-01, 67877-0436-05, 67877-0436-14, 67877-0436-30, 67877-0437, 67877-0437-01, 67877-0437-05, 67877-0437-14, 67877-0437-30, 67877-0438, 67877-0438-01, 67877-0438-05, 67877-0438-14, 67877-0438-30, 67877-0576, 67877-0576-01, 67877-0576-05, 67877-0576-14, 67877-0576-30, 67877-0577, 67877-0577-01, 67877-0577-05, 67877-0577-14, 67877-0577-30 and 15 more |
| Lot numbers | 19140414 |
| Expiration dates | 2020-12 |
Product
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
Reason for recall
Failed Dissolution Specifications: low out of specification results for dissolution 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-0827-2020. 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.