FDAHealthJune 1, 2026
Ascend Laboratories, LLC — Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratori
⚠️ Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 1, 2026
Nationwide in the USA
What's affected?
- 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
- Lot code
- 25141635
Additional details
Lot# 25141635, Exp 4/30/2028
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 360 30-count bottles.
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