Major Pharmaceuticals recalled Gabapentin Capsules, USP, 100 mg, on October 10, 2025, due to failed impurities specifications. The recall affects several lot numbers distributed nationwide. Consumers must stop using the affected capsules immediately.
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC or your healthcare provider for guidance
The recalled product includes Gabapentin Capsules, USP, 100 mg in 10-capsule blister packs. Lot numbers involved are M04989A, M05056A, M05150A, M05312A, and M05342A. The product was packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, and is classified as a prescription medication.
The recall stems from an out-of-specification result related to an unknown impurity detected during routine stability testing. This impurity poses a potential health risk, as it may affect the efficacy and safety of the medication.
No specific incidents or injuries have been reported related to this recall. The risk level associated with the impurity issue is classified as high.
Consumers and healthcare providers should immediately stop using the recalled Gabapentin Capsules. Contact The Harvard Drug Group LLC or your healthcare provider for further guidance and potential returns.
For more information, call The Harvard Drug Group LLC at 1-800-XXX-XXXX. Additional details are available at the FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0031-2026.
Get notified about recalls in categories you care about.
Bristol-Myers Squibb recalled 12,778 vials of Opdualag injection on October 21, 2025. The recall stems from a lack of assurance of sterility. The affected products were distributed nationwide in the United States.
Lannett Company, Inc. recalled 46,848 bottles of Niacin Extended-release Tablets on October 10, 2025. The recall follows reports of failed dissolution specifications, which could affect medication effectiveness. Consumers should stop using the product immediately and consult healthcare providers for guidance.
Major Pharmaceuticals recalled Gabapentin Capsules, USP, 100 mg on October 10, 2025, due to failed stability testing. The recall affects capsules packaged in blister packs and sold nationwide. Consumers must stop using the product immediately and seek guidance from healthcare providers.