Recalls / Class II
Class IID-0576-2025
Product
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
- Brand name
- Amlodipine And Olmesartan Medoxomil
- Generic name
- Amlodipine And Olmesartan Medoxomil
- Active ingredients
- Amlodipine Besylate, Olmesartan Medoxomil
- Route
- Oral
- NDCs
- 67877-499, 67877-500, 67877-501, 67877-502
- FDA application
- ANDA209042
- Affected lot / code info
- Lot 23121560, Exp 4/30/2026
Why it was recalled
Failed Dissolution Specifications: low dissolution results
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 135 Us Highway 202 206 Ste 15, N/A, Bedminster, New Jersey 07921-2608
Distribution
- Quantity
- 8,568 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-07-21
- FDA classified
- 2025-08-08
- Posted by FDA
- 2025-08-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0576-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.