Ascend Laboratories, LLC: Drug Recall
Recall #D-0018-2026 · 09/19/2025
Class II: Risk
Recall Details
- Recall Number
- D-0018-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Ascend Laboratories, LLC
- Status
- Ongoing
- Date Initiated
- 09/19/2025
- Location
- Bedminster, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
Reason for Recall
Failed Dissolution Specifications
Product Description
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Distribution Pattern
U.S. Nationwide
Other Recalls by Ascend Laboratories, LLC
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 08/28/2025
- Class II: Risk 07/21/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.