Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, ND
Summary
The FDA issued a Class III for Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC by SUN PHARMACEUTICAL INDUSTRIES INC. Reason: Cross Contamination.
Details
Source
Drug Recall
External ID
D-0311-2025
Action Date
2025-04-16
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot # a) HAD1458A, Exp. date 04/2025, HAD2718A, Exp. date 07/2025, b) HAD3432A, exp. date 08/2025
Quantity Affected: 12,876 bottles
Reason for Recall
Cross Contamination
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-04
Company
Princeton, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 86 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 clearance.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SUN PHARMACEUTICAL INDUSTRIES INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUN PHARMACEUTICAL INDUSTRIES INC have FDA actions?
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0311-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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