Home / Recalls / Ascend Laboratories, LLC / D-0597-2026

D-0597-2026 Class II Ongoing

Recalled by Ascend Laboratories, LLC — Bedminster, NJ

Recall Details

Product Type
Drugs
Report Date
June 17, 2026
Initiation Date
June 1, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
360 30-count bottles

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

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot# 25141635, Exp 4/30/2028

Other recalls by Ascend Laboratories, LLC

  • D-0556-2026 Class II — Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, (May 5, 2026)
  • D-0547-2026 Class II — Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 (April 27, 2026)
  • D-0020-2026 Class II — Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90) (September 19, 2025)
  • D-0018-2026 Class II — Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-9 (September 19, 2025)
  • D-0017-2026 Class II — Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-5 (September 19, 2025)
  • D-0019-2026 Class II — Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90) (September 19, 2025)
  • D-0645-2025 Class II — Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Al (August 28, 2025)
  • D-0576-2025 Class II — Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx On (July 21, 2025)
  • D-0534-2025 Class II — Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, M (July 9, 2025)
  • D-0533-2025 Class II — Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Ma (July 9, 2025)