October 2026 FDA Recall Amlodipine And Olmesartan Medoxomil by Ascend Laboratories, Llc
D-0045-2027 - Out of specification due to dissolution.
This Class II drug recall was voluntarily initiated by Ascend Laboratories, Llc on October 6, 2026 for the product Amlodipine And Olmesartan Medoxomil. The FDA reported the reason for recall as out of specification due to dissolution.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0045-2027
Out of specification due to dissolution.
10-06-2026
10-28-2026
11,424 bottles.
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ascend Laboratories, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-502-30.
Batch or Lot Expiration Information
Lot# 25120696, Exp Date: December 31, 2026.
