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Ascend Laboratories, LLC: Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distribute

DrugsSource: FDA (drug) · Date: 2026-06-10

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Ascend Laboratories, LLC
Product
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.
Reason / hazard
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S.A. Nationwide
Recall initiated
2026-05-05
Code info
Lot: 24123460, Expires: October 31, 2027.
Product quantity
15,696 x 30's bottles
Voluntary mandated
Voluntary: Firm initiated
City
Bedminster
State
NJ
Country
United States
Event id
98874
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