Zolpidem Tartrate Extended-Release Tablets Recalled for Manufacturing Contamination
SUN PHARMACEUTICAL INDUSTRIES is recalling 14,568 bottles of Zolpidem Tartrate Extended-Release 12.5mg tablets nationwide due to microbial contamination discovered in manufacturing equipment. Affected lot: DNE0893A (expires 07/31/2026).
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a drug recall involving microbial contamination in manufacturing, representing a risk-of-harm product. No illnesses or injuries have been reported. The contamination in drug manufacturing is a serious CGMP violation that could pose health risk if consumed, but without reported illness, this meets the High threshold.
Plain-English summary
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg (NDC 47335-308-88 and related package codes) distributed nationwide. The recall affects 14,568 bottles in lot DNE0893A with an expiration date of 07/31/2026.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, microbial contamination was detected in stagnant water found in a duct of the manufacturing equipment. This contamination presents a potential health risk if the affected product was used.
Consumers and healthcare providers in possession of affected bottles should not use this medication. Patients currently taking this product should consult their healthcare provider or pharmacist for guidance. Bottles should be returned to the pharmacy where they were obtained or disposed of safely according to local regulations.
The recalled product
- Product
- ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
- Brand
- ZOLPIDEM TARTRATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Sedative/Sleep Aid
- Affected units
- 14,568
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 #: DNE0893A Expires 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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