Ascend Laboratories recalls Minocycline Hydrochloride Extended-Release Tablets after failed dissolution test
One test of the tablets at the 9th month gave a result outside the allowed limits for dissolution, and the notice lists 360 30-count bottles sold nationwide in the USA.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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
- Company
- Ascend Laboratories, LLC
- Hazard
- Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
- Units
- 360 30-count bottles
- Where sold
- Nationwide in the USA
- FDA classification
- Class II · Ongoing
- Classified by FDA
- June 17, 2026
- Recall started
- June 1, 2026
- FDA enforcement report
- June 17, 2026
- Identifiers
- Codes: Lot# 25141635, Exp 4/30/2028
- FDA recall number: D-0597-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 for recall
- Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 360 30-count bottles
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