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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 1,220
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.
Part of a larger recall action
This product is one of 11 recalled by SUN PHARMACEUTICAL INDUSTRIES INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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