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.
Reason
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Classification
Class II
Status
Completed
Lot
Lot #: DNE0892A Exp. 07/31/2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
SUN PHARMACEUTICAL INDUSTRIES INC — Class II Recall | MedicineWatch US