FDA-Drug2026-06-17Class IIPROCESSING DEFECT
Ascend Laboratories Minocycline 115 mg tablets recalled for failed dissolution specifications
What this means
Ascend Laboratories is recalling Minocycline Hydrochloride Extended-Release Tablets, 115 mg (lot 25141635, expires 4/30/2028) because testing found the tablets did not dissolve properly as required. This affects 360 bottles distributed nationwide. No injuries have been reported.
- Check if you have lot 25141635 (expiring 4/30/2028) of Ascend Minocycline 115 mg tablets.
- Contact your pharmacist or doctor about whether to continue taking this medication.
- Do not flush or throw away the medication; ask your pharmacist how to safely dispose of it.
The agency's original wording
Hazard
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
360 30-count bottles
Manufactured in
135 Us Highway 202 206 Ste 15, N/A, Bedminster, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0597-2026More Ascend Laboratories recalls
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