FDA Drug recall D-0339-2025
Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, I…
- FDA Drug
- Class II
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class II recall of Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, I… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0339-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-13 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
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
Reason
CGMP Deviations
Identifiers
| ndc | 68462-261-30 |
|---|---|
| ndc | 68462-261-50 |
| ndc | 68462-261-90 |
| ndc | 68462-261-01 |
| ndc | 68462-261-10 |
| ndc | 68462-261-11 |
| ndc | 68462-262-30 |
| ndc | 68462-262-50 |
| ndc | 68462-262-90 |
| ndc | 68462-262-01 |
| ndc | 68462-262-10 |
| ndc | 68462-262-11 |
| ndc | 68462-263-30 |
| ndc | 68462-263-50 |
| ndc | 68462-263-90 |
| ndc | 68462-263-01 |
| ndc | 68462-263-10 |
| ndc | 68462-263-11 |
| ndc | 68462-264-30 |
| ndc | 68462-264-50 |
| ndc | 68462-264-90 |
| ndc | 68462-264-01 |
| ndc | 68462-264-05 |
| ndc | 68462-264-10 |
| code_info | Lot # 17240389, exp. date Feb-26 17240390, exp. date Feb-26 17240426, exp. date Feb-26 17240427, exp. date Feb-26 1724…Lot # 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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0339-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.