Why it was recalled
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0018-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 19, 2025
- FDA report date
- Oct 22, 2025
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-0018-2026, exactly as published.
Show all FDA fields
- City
- Bedminster
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97639
- Address
- 135 Us Highway 202 206 Ste 15
- Code information
- 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
- Postal code
- 07921-2608
- Report date
- Oct 22, 2025
- Product type
- Drugs
- Recall number
- D-0018-2026
- Classification
- Class II
- Recalling firm
- Ascend Laboratories, LLC
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Sep 19, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 10, 2025