Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b)...
FDA Recall #D-0311-2025 — Class III — March 4, 2025
Product Description
Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Reason for Recall
Cross Contamination
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
12,876 bottles
Distribution
Nationwide in the USA
Code Information
Lot # a) HAD1458A, Exp. date 04/2025, HAD2718A, Exp. date 07/2025, b) HAD3432A, exp. date 08/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated