Class IIOngoing
Ascend Laboratories, LLC recalls Amlodipine and Olmesartan Medoxomil Tablets
Recall date · record updated Jul 29, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)
Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.
- Company
- Ascend Laboratories, LLC
- Reason
- Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
- Hazard
- FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
- Who’s affected
- Nationwide in the USA
- Where
- Nationwide
- Official notice
- www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99385…
Products
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
Codes/lots: Lot 25121311, expiry 3/31/2028Quantity: 6,192 bottlesRecall no. D-0712-2026Class II
Update history
- First listed on OVERLOOKED from the official record.
When the agency expands or changes this recall, we update this page and log the change here.
Proof: raw official record (JSON) · fetched from FDA API
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