Zolpidem Tartrate Tablet, Film Coated, Extended Release
FDA Recall NDC 47335-307
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Zolpidem Tartrate (NDC 47335-307). A significant event, classified as Class II, was initiated on Jan 18, 2024 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Jan 18, 2024
Jan 31, 2024
1220 bottles
Recall Profile & Regulatory Data
Event ID
93820
Classification
Class II
Enforcement Status
Completed
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, 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 47335-307-88.
Batch or Lot Expiration Information
Lot# : DNE0892A Exp. 07/31/2026
Affected Packages Involved in this Recall
47335-307-88Product
47335-307-13Product
47335-308-88Product
47335-308-13Product
Class II Completed
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Jan 18, 2024
Jan 31, 2024
14,568 bottles
Recall Profile & Regulatory Data
Event ID
93820
Classification
Class II
Enforcement Status
Completed
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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.
Batch or Lot Expiration Information
Lot# : DNE0893A Expires 07/31/2026
Affected Packages Involved in this Recall
47335-307-88Product
47335-307-13Product
47335-308-88Product
47335-308-13Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
