Class II · ModerateActive recall
Rosuvastatin Calcium
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # 17240389, exp. date Feb-26 17240390, exp. date Feb-26 17240426, exp. date Feb-26 17240427, exp. date Feb-26 17240428, exp. date Feb-26 17240778, exp. date Apr-26 17241055, exp. date May-26 17241074, exp. date Jun-26 17241075, exp. date Jun-26 17241091, exp. date Jun-26 17241100, exp. date Jun-26
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
CGMP Deviations
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 byGlenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 foreign manufacturer
| Brand name | ROSUVASTATIN CALCIUM |
| Generic name | ROSUVASTATIN CALCIUM |
| Active ingredient(s) | ROSUVASTATIN CALCIUM |
| Distributed by / for | Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 |
| NDC | 68462-264-30 |
Show the full FDA record
| Full product label | Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-264-30 |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall initiated | 2025-03-13 |
| Report date | 2025-04-16 |
| Recall completed | — |
| Recall number | D-0339-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Mahwah 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.