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Home › FDA recalls › Amlodipine and Olmesartan Medoxomil Tablets
CLASS II · ModerateFDA

Ascend Laboratories, LLC recalls Amlodipine and Olmesartan Medoxomil Tablets

📅 Oct 6, 2026 · 📍 Nationwide
Recalling company
Ascend Laboratories, LLC
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.
Reason
Out of specification due to dissolution.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 6, 2026
Reported
Oct 28, 2026
Distribution
Nationwide within the United States
Status
Ongoing
Quantity
11,424 bottles.
Lot / codes
Lot # 25120696, Exp Date: December 31, 2026.
Company location
Bedminster, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0045-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0045-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.