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, 30-count bottles) distributed nationwide because the tablets failed to meet dissolution specifications during stability testing, meaning they may not break down in the body as intended. The recall affects prescription bottles with NDC 67877-644-30 manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories in New Jersey. This is classified as a Class II recall, affecting patients in all 50 states and Washington, DC.
- 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/f751f329-deb2-48c7-93d6-efdc9b1c7244