Recall of Gabapentin Capsules Due to Inadequately Sealed Blister Packaging

The US Food and Drug Administration (FDA) has announced a Class II recall for Gabapentin Capsules, USP, 100 mg, due to a defective container issue involving inadequately sealed blister packaging. The affected products include 23 232 cartons (10x10 count) and 3527 bags (10x1 count), all with an expiration date of October 2026. These products were packaged and distributed by Major Pharmaceuticals of Indianapolis, IN, and distributed nationwide under NDCs 0904-6665-61 and 55154-3363-0. The recall was initiated on June 19, 2025, and applies to lot numbers M05205, M05205A, and M05205B.

The recalling firm, The Harvard Drug Group LLC, based in Dublin, Ohio, voluntarily initiated the recall, which was later classified as Class II by the FDA on July 3, 2025. This classification signifies that use of the product could result in temporary or medically reversible health effects, with serious adverse health consequences considered unlikely. The defect may compromise the protection and stability of the capsules, particularly in environments with fluctuating humidity or temperature, thereby potentially affecting product efficacy.

Gabapentin is an anticonvulsant and nerve pain medication indicated for the treatment of partial-onset seizures and postherpetic neuralgia. Proper container integrity is essential to maintaining dosage stability and therapeutic consistency.