Recalling firm
Ascend Laboratories, LLC
Product type
Drug
Status
Ongoing
Report date
2026-06-10
Distribution
U.S.A. Nationwide
Firm state
NJ
Product quantity
15,696 x 30's bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Product description
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.
Code / lot info
Lot: 24123460, Expires: October 31, 2027.
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →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.