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Class II · ModerateActive recall

Minocycline Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot# 25141635, Exp 4/30/2028
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAlkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 foreign manufacturer
Brand nameMINOCYCLINE HYDROCHLORIDE
Generic nameMINOCYCLINE HYDROCHLORIDE
Active ingredient(s)MINOCYCLINE HYDROCHLORIDE
Distributed by / forAscend Laboratories, LLC, Parsippany, NJ 07054
NDC67877-644-30
Show the full FDA record
Full product labelMinocycline 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
Recalling firmAscend Laboratories, LLC
DistributionNationwide in the USA
Quantity360 30-count bottles
Recall initiated2026-06-01
Report date2026-06-17
Recall completed—
Recall numberD-0597-2026
ClassificationClass II
FDA statusOngoing
Origin on fileBedminster NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.