Ascend Laboratories, Llc: Minocycline Hydrochloride Extended-release Tablets, Usp, 115 Mg, 30-count Bottle
Recall Summary Ascend Laboratories is recalling Minocycline Hydrochloride Extended-Release Tablets 115 mg (a prescription antibiotic) distributed nationwide because the medication failed to meet dissolution specifications during testing, meaning it may not break down in the body as intended. The recall affects 30-count bottles distributed across all U.S. states and Washington, D.C. Patients currently taking this medication from affected bottles should contact their healthcare provider or pharmacist.
- Recalling firm
- Ascend Laboratories, LLC
- 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
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-01
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/f39f6b82-68c1-41e8-87b2-a59c1f6088c5