FDA recall, , Moderate risk
Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets
Amlodipine and Olmesartan Medoxomil Tablets 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 is recalling Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, manufactured by Alkem Laboratories Ltd., INDIA and distributed by Ascend Laboratories, LLC, because the product failed dissolution specifications and had Olmesartan Medoxomil content below specifications.
The recall began July 8, 2026, was added to the FDA's Enforcement Report on July 17, 2026, and classified on July 20, 2026. The product was distributed nationwide in the USA.
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 yours 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
- NDC
- 67877-500-30
- UPC
- 25121311
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- 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
- 99385
- Recall number
- D-0712-2026
- Quantity recalled
- 6,192 bottles
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
