Why it was recalled
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Product description
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 numbers, UPCs & expiration codes
Lot# 25141635, Exp 4/30/2028
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0597-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 1, 2026
- FDA report date
- Jun 17, 2026
- Quantity
- 360 30-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-0597-2026, exactly as published.
Show all FDA fields
- City
- Bedminster
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99129
- Address
- 135 Us Highway 202 206 Ste 15
- Code information
- Lot# 25141635, Exp 4/30/2028
- Postal code
- 07921-2608
- Report date
- Jun 17, 2026
- Product type
- Drugs
- Recall number
- D-0597-2026
- Classification
- Class II
- Recalling firm
- Ascend Laboratories, LLC
- Product quantity
- 360 30-count bottles
- Reason for recall
- Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 1, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 17, 2026