FDA recall, , Moderate risk
Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets
Amlodipine and Olmesartan Medoxomil Tablets are out of specification due to dissolution.
Summary by Recall Canary from the FDA notice
What happened
Ascend Laboratories, LLC is recalling Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, manufactured by Alkem Laboratories Ltd., INDIA, and distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, because the product is out of specification due to dissolution. The recall, which began October 6, 2026, was added to the FDA's Enforcement Report on October 16, 2026, and covers 11,424 bottles distributed nationwide within the United States.
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?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Amlodipine and Olmesartan Medoxomil Tablets
- NDC
- 67877-502-30
- Lot code
- 25120696
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Ascend Laboratories, LLC
- 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
- 100053
- Recall number
- D-0045-2027
- Quantity recalled
- 11,424 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
