Minocycline Hydrochloride Extended-Release Tablets — Class II drug recall D-0597-2026
Ongoing recall by Ascend Laboratories, LLC, reported 2026-06-17, distributed nationwide. Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of d
| Recall number | D-0597-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Bedminster, NJ, United States |
| Recall initiated | 2026-06-01 |
| Classified | 2026-06-17 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| 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 | 25141635 |
| Expiration dates | 2028-04-30 |
Product
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30
Reason for recall
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
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-0597-2026. 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.