FDA recall, , Moderate risk
Ascend Laboratories Minocycline Hydrochloride Extended-Release Tablets
Minocycline Hydrochloride Extended-Release Tablets failed dissolution specifications during testing.
Summary by Recall Canary from the FDA notice
What happened
Ascend Laboratories, LLC, of Bedminster, New Jersey, is recalling Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottles, distributed nationwide in the USA. The recall began June 1, 2026, after an out-of-specification result was observed during the 9th month of dissolution test analysis. The product is manufactured by Alkem Laboratories Ltd., India, and was added to the FDA's Enforcement Report on June 10, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Affected if its NDC or UPC is listed.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle
- NDC
- 67877-644-30
- UPC
- 25141635
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- Ascend Laboratories, LLCBedminster, New Jersey
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99129
- Recall number
- D-0597-2026
All recalls from Ascend Laboratories, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
Classified by FDA · In FDA's weekly enforcement report
Summary updated
