Zolpidem Tartrate Tablets Recalled Due to Manufacturing Equipment Contamination
Sun Pharmaceutical is recalling approximately 1220 bottles of Zolpidem Tartrate Extended-Release 6.25 mg tablets distributed nationwide due to microbial contamination detected in manufacturing equipment.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. Microbial contamination detected in manufacturing equipment constitutes a low-risk, precautionary recall scenario.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg in 100-tablet bottles. The recall affects approximately 1220 bottles that were distributed nationwide in the United States. The affected lot is DNE0892A with an expiration date of 07/31/2026.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. Specifically, microbial contamination was discovered in stagnant water found within the duct of manufacturing equipment.
Patients currently taking this medication should consult their healthcare provider or pharmacist before making any changes to their treatment. Consumers who have this medication and have questions should contact Sun Pharmaceutical Industries, Inc. or the FDA.
The recalled product
- Product
- ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
- Brand
- ZOLPIDEM TARTRATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- microbial-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: DNE0892A Exp. 07/31/2026
UPCs (2)
- 0347335307887
- 0347335308884
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ZOLPIDEM TARTRATE
- HighZolpidem Tartrate Extended-Release Tablets Recalled for Manufacturing Contamination
FDA (Drugs) · 2024-01-31
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27