FDA recall, , Moderate risk
Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets
Amlodipine and Olmesartan Medoxomil Tablets have failed dissolution specifications, with olmesartan medoxomil content below specifications.
Summary by Recall Canary from the FDA notice
What happened
Ascend Laboratories, LLC, of Bedminster, New Jersey, recalled Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, manufactured by Alkem Laboratories Ltd., India, and distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, because the olmesartan medoxomil content was below specifications. The recall began May 5, 2026, and the product was distributed nationwide in the U.S.A.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Affected if its NDC or UPC is listed.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle
- NDC
- 67877-501-30
- UPC
- 24123460
Recall details
- Company began the recall
- Sold in
U.S.A. Nationwide
- Company
- Ascend Laboratories, LLCBedminster, New Jersey
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98874
- Recall number
- D-0556-2026
All recalls from Ascend Laboratories, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
