Why it was recalled
Failed Dissolution Specifications: low dissolution results
Product description
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
Lot numbers, UPCs & expiration codes
Lot 23121560, Exp 4/30/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0576-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 21, 2025
- FDA report date
- Aug 20, 2025
- Quantity
- 8,568 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-0576-2025, exactly as published.
Show all FDA fields
- City
- Bedminster
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97293
- Address
- 135 Us Highway 202 206 Ste 15
- Code information
- Lot 23121560, Exp 4/30/2026
- Postal code
- 07921-2608
- Report date
- Aug 20, 2025
- Product type
- Drugs
- Recall number
- D-0576-2025
- Classification
- Class II
- Recalling firm
- Ascend Laboratories, LLC
- Product quantity
- 8,568 bottles
- Reason for recall
- Failed Dissolution Specifications: low dissolution results
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 21, 2025
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2025