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.
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 is Gabapentin Capsules, USP, 100 mg, packaged in blister packs of 100 capsules. The lot numbers include M04950, M04989, M04990, M05056, M05150, M05290, M05312, M05342, M05369, and M05386. The capsules were distributed nationwide.
The recall was initiated due to the presence of highest unknown impurity levels that exceeded acceptable specifications during routine stability testing. This poses a serious health risk to consumers.
There have been no reported injuries or deaths related to this recall as of now. The FDA classified this recall as Class II, indicating a moderate risk.
Consumers should stop using the recalled Gabapentin Capsules immediately. Contact The Harvard Drug Group LLC or your healthcare provider for guidance on next steps.
For further assistance, call The Harvard Drug Group LLC or visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0030-2026.
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