Class II · ModerateActive recall
Atorvastatin Calcium
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot#: 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 soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Dissolution Specifications
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAlkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 foreign manufacturer
| Brand name | ATORVASTATIN CALCIUM |
| Generic name | ATORVASTATIN CALCIUM |
| Active ingredient(s) | ATORVASTATIN CALCIUM TRIHYDRATE |
| Distributed by / for | Ascend Laboratories, LLC, Parsippany, NJ 07054 |
| NDC | 67877-513-90 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Ascend Laboratories, LLC |
| Distribution | U.S. Nationwide |
| Recall initiated | 2025-09-19 |
| Report date | 2025-10-22 |
| Recall completed | — |
| Recall number | D-0018-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Bedminster NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.