FDA Drug recall D-0272-2024
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc…
- FDA Drug
- Class II
- completed
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc… by Sun Pharmaceutical Industries, citing CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0272-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2024-01-18 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88.
Reason
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Identifiers
| ndc | 47335-307-88 |
|---|---|
| ndc | 47335-307-13 |
| ndc | 47335-308-88 |
| ndc | 47335-308-13 |
| code_info | Lot #: DNE0893A Expires 07/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0272-2024%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.