FDA Drug recall D-0597-2026
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA.…
- FDA Drug
- Class II
- ongoing
- Published 2026-06-17
On 2026-06-17 the FDA classified a Class II recall of Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA.… by Ascend Laboratories, citing failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0597-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-01 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
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
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Identifiers
| ndc | 67877-578-14 |
|---|---|
| ndc | 67877-578-30 |
| ndc | 67877-578-01 |
| ndc | 67877-578-05 |
| ndc | 67877-576-14 |
| ndc | 67877-576-30 |
| ndc | 67877-576-01 |
| ndc | 67877-576-05 |
| ndc | 67877-577-14 |
| ndc | 67877-577-30 |
| ndc | 67877-577-01 |
| ndc | 67877-577-05 |
| ndc | 67877-643-14 |
| ndc | 67877-643-30 |
| ndc | 67877-643-01 |
| ndc | 67877-643-05 |
| ndc | 67877-644-14 |
| ndc | 67877-644-30 |
| ndc | 67877-644-01 |
| ndc | 67877-644-05 |
| ndc | 67877-436-14 |
| ndc | 67877-436-30 |
| ndc | 67877-436-01 |
| ndc | 67877-436-05 |
| ndc | 67877-437-14 |
| ndc | 67877-437-30 |
| ndc | 67877-437-01 |
| ndc | 67877-437-05 |
| ndc | 67877-438-14 |
| ndc | 67877-438-30 |
| ndc | 67877-438-01 |
| ndc | 67877-438-05 |
| code_info | Lot# 25141635, Exp 4/30/2028 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0597-2026%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.