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
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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.
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