Gabapentin Capsules Recalled Due to Cross-Contamination Concerns

The US Food and Drug Administration (FDA) has announced a Class III recall for select lots of Gabapentin Capsules USP, 300 mg and 400 mg, manufactured by Sun Pharmaceutical Industries Ltd. in Gujarat, India, and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, New Jersey. The recall affects 13 728 bottles—12 876 bottles of 300 mg capsules and 852 bottles of 400 mg capsules—due to concerns of cross contamination during manufacturing. The impacted lots, with expiration dates ranging from March to August 2025, were distributed nationwide across the United States. The voluntary recall was initiated on March 4, 2025, and remains ongoing.

The recalling firm, Sun Pharmaceutical Industries Inc., notified its consignees via letter. The FDA classified this action as a Class III recall on April 4, 2025, meaning use of the affected product is not likely to cause adverse health consequences, but the potential for quality issues still warrants precautionary removal. While no public press release has been issued, pharmacists are encouraged to verify inventory for lot numbers HAD1458A, HAD2718A, HAD3432A (300 mg) and HAD1712B, HAD1712C (400 mg) and ensure proper quarantine and return procedures are followed.

Gabapentin is commonly prescribed for the management of postherpetic neuralgia and as adjunctive therapy in the treatment of partial-onset seizures in adults and pediatric patients.