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) in 30-count bottles nationwide because testing found the medication did not dissolve properly as specified. The affected product was manufactured by Alkem Laboratories Ltd. in India and distributed across all U.S. states and Washington, D.C.
- 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
- 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/65203018-a4b0-435c-af60-8752d6c9ea7a