Recalls / Class II
Class IID-0018-2026
Product
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.
- Brand name
- Atorvastatin Calcium
- Generic name
- Atorvastatin Calcium
- Active ingredient
- Atorvastatin Calcium Trihydrate
- Route
- Oral
- NDCs
- 67877-511, 67877-512, 67877-513, 67877-514
- FDA application
- ANDA209288
- Affected lot / code info
- Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 135 Us Highway 202 206 Ste 15, Bedminster, New Jersey 07921-2608
Distribution
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-09-19
- FDA classified
- 2025-10-10
- Posted by FDA
- 2025-10-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0018-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.