FDAFDA recall D-0712-2026 · Jul 29, 2026
Ascend Laboratories, LLC: Amlodipine and Olmesartan Medoxomil Tablets recall
Recall found
Product
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30
Reason for recall
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot 25121311, expiry 3/31/2028
- Quantity
- 6,192 bottles
- Distribution
- Nationwide in the USA
- Recalling firm
- Ascend Laboratories, LLC, Bedminster, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-08
Source: openFDA enforcement record D-0712-2026 · search recall number D-0712-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.