Ascend Laboratories, LLC recalls Minocycline Hydrochloride Extended-Release Tablets
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Jun 1, 2026
- Reported
- Jun 17, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 360 30-count bottles
- Lot / codes
- Lot# 25141635, Exp 4/30/2028
- Company location
- Bedminster, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0597-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0597-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.