Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
- Agency
- FDA Drug
- Recall date
- Jun 1, 2026
- Status
- Ongoing
- Company
- Ascend Laboratories, LLC
1. What product was recalled?
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd
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
Quantity: 360 30-count bottles
Code or lot text: Lot# 25141635, Exp 4/30/2028
- LOT
- Exp 4/30/2028
- LOT
- Lot# 25141635
- NDC
- 67877-436
- NDC
- 67877-436-01
- NDC
- 67877-436-05
- NDC
- 67877-436-14
- NDC
- 67877-436-30
- NDC
- 67877-437
- NDC
- 67877-437-01
- NDC
- 67877-437-05
- NDC
- 67877-437-14
- NDC
- 67877-437-30
- NDC
- 67877-438
- NDC
- 67877-438-01
- NDC
- 67877-438-05
- NDC
- 67877-438-14
- NDC
- 67877-438-30
- NDC
- 67877-576
- NDC
- 67877-576-01
- NDC
- 67877-576-05
- NDC
- 67877-576-14
- NDC
- 67877-576-30
- NDC
- 67877-577
- NDC
- 67877-577-01
- NDC
- 67877-577-05
- NDC
- 67877-577-14
- NDC
- 67877-577-30
- NDC
- 67877-578
- NDC
- 67877-578-01
- NDC
- 67877-578-05
- NDC
- 67877-578-14
- NDC
- 67877-578-30
- NDC
- 67877-643
- NDC
- 67877-643-01
- NDC
- 67877-643-05
- NDC
- 67877-643-14
- NDC
- 67877-643-30
- NDC
- 67877-644
- NDC
- 67877-644-01
- NDC
- 67877-644-05
- NDC
- 67877-644-14
- NDC
- 67877-644-30
- RECALL-NUMBER
- D-0597-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Drug source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.