Drug recall D-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
Reason for recall
Failed Dissolution Specifications: low dissolution results
Lots and codes
Lot 23121560, Exp 4/30/2026
Recall details
- Recalling firm
- Ascend Laboratories, LLC, Bedminster, NJ
- Quantity
- 8,568 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 21, 2025
Related products
- Amlodipine and Olmesartan Medoxomil – drug information
- NDC 67877-499 Amlodipine and olmesartan Medoxomil · Amlodipine Besylate 5 mg/1; Olmesartan Medoxomil 20 mg/1 · Ascend Laboratories, LLC
- NDC 67877-500 Amlodipine and olmesartan Medoxomil · Amlodipine Besylate 10 mg/1; Olmesartan Medoxomil 20 mg/1 · Ascend Laboratories, LLC
- NDC 67877-502 Amlodipine and olmesartan Medoxomil · Amlodipine Besylate 10 mg/1; Olmesartan Medoxomil 40 mg/1 · Ascend Laboratories, LLC
- NDC 67877-501 Amlodipine and olmesartan Medoxomil · Amlodipine Besylate 5 mg/1; Olmesartan Medoxomil 40 mg/1 · Ascend Laboratories, LLC