← FDA ENFORCEMENT
D-0576-2025Class II

Ascend Laboratories, LLC

Recalling firm
Ascend Laboratories, LLC
Product type
Drug
Status
Ongoing
Report date
2025-08-20
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
8,568 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Dissolution Specifications: low dissolution results

Product description

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30

Code / lot info

Lot 23121560, Exp 4/30/2026

Other recalls SPEQ maps to Validation & Qualification
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.