FDAFDA · Food and drugs·Recall number D-0018-2026
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.
Published October 22, 2025 · Recall initiated: September 19, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Ascend Laboratories, LLC
- Distributor
- U.S. Nationwide
- UPC
- 0367877512051
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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