Gabapentin Capsules Recalled Due to Stability Failure and Elevated Unknown Impurity

The US Food and Drug Administration (FDA) has issued a Class II recall for Gabapentin Capsules, USP, 100 mg, packaged in 10 x 10 and 10 x 1 blister packs, after routine stability testing revealed out-of-specification results for an unknown degradation impurity. The recall affects multiple lots—including M04950, M04989, M04990, M05056, M05150, M05290, M05312, M05342, M05369, and M05386—with expiration dates spanning from January 2026 to February 2027. The affected products were packaged and distributed by Major Pharmaceuticals, based in Indianapolis, IN, and the recall was initiated on October 10, 2025, following voluntary action by The Harvard Drug Group LLC.

The recall was officially classified by the FDA as Class II on October 17, 2025, indicating that use of the product may cause temporary or medically reversible adverse health effects, but the risk of serious injury is considered low. The affected gabapentin was distributed nationwide in the United States.

Gabapentin is widely prescribed as an antiepileptic and nerve pain medication, indicated for the treatment of partial-onset seizures and postherpetic neuralgia. Consistent drug quality is essential for maintaining therapeutic levels, especially in long-term treatment. Pharmacists are advised to review inventory for impacted lots under NDC 0904-6665-61 (blister packs) and NDC 55154-3363-0 (outer bag), segregate any affected stock, and inform prescribers and patients about the recall.

Reference

FDA. Enforcement Report. October 22, 2025. Accessed October 23, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm