FDAFDA · Food and drugs·Recall number D-0597-2026
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
Published June 17, 2026 · Recall initiated: June 1, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MINOCYCLINE HYDROCHLORIDE
- Manufacturer
- Ascend Laboratories, LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot# 25141635, Exp 4/30/2028
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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