Medications & Supplements/Prescription Drugs

Major Pharmaceuticals Gabapentin Capsules Recalled for Defective Packaging

Agency Publication Date: July 3, 2025

Summary

The Harvard Drug Group LLC is recalling approximately 26,759 units of Gabapentin Capsules (100 mg) sold under the Major Pharmaceuticals brand because the blister packaging may not be properly sealed. This recall includes Gabapentin dispensed in 100-count blister pack cartons and 10-count bags distributed nationwide. Consumers are advised that an inadequate seal could compromise the product's integrity.

Risk

A defective or inadequate seal on blister packaging can expose the medication to air and moisture, potentially reducing the drug's effectiveness or leading to contamination. This is particularly concerning for medications like Gabapentin used to treat seizures or nerve pain, where consistent dosing is critical.

What You Should Do

This recall affects Major Pharmaceuticals Gabapentin Capsules (USP, 100 mg) sold in 100-count blister pack cartons (NDC 0904-6665-61) and 10-count bags (NDC 55154-3363-0).
Affected products are identified by lot numbers M05205, M05205A, and M05205B, all with an expiration date of October 2026. The NDC code can be found on the outer carton or bag label.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Gabapentin Capsules, USP, 100 mg (100 capsules)by Major Pharmaceuticals

Variants: 100 mg, 100 capsules (10x10) blister pack cartons

Lot Numbers:

M05205 (Exp 10/2026)

NDC:

0904-6665-61

Packaged and Distributed by: MAJOR PHARMACEUTICALS; Recall #: D-0507-2025; Quantity: 23,232 cartons

Product: Gabapentin Capsules, USP, 100 mg (10 capsules)by Major Pharmaceuticals

Variants: 100 mg, 10 capsules (10x1) per bag

Lot Numbers:

M05205A (Exp 10/2026)

M05205B (Exp 10/2026)

NDC:

55154-3363-0

Distributed by Cardinal Health; Recall #: D-0508-2025; Quantity: 3,527 bags

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97087

Status: Active

Manufacturer: The Harvard Drug Group LLC

Sold By: Cardinal Health; Major Pharmaceuticals; Pharmacies

Manufactured In: United States

Units Affected: 2 products (23,232 cartons; 3,527 bags)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects Major Pharmaceuticals Gabapentin Capsules (USP, 100 mg) sold in 100-count blister pack cartons (NDC 0904-6665-61) and 10-count bags (NDC 55154-3363-0).

Affected products are identified by lot numbers M05205, M05205A, and M05205B, all with an expiration date of October 2026. The NDC code can be found on the outer carton or bag label.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Gabapentin Capsules, USP, 100 mg (100 capsules)by Major Pharmaceuticals

Variants: 100 mg, 100 capsules (10x10) blister pack cartons

Lot Numbers:

M05205 (Exp 10/2026)

NDC:

0904-6665-61

Packaged and Distributed by: MAJOR PHARMACEUTICALS; Recall #: D-0507-2025; Quantity: 23,232 cartons

Product: Gabapentin Capsules, USP, 100 mg (10 capsules)by Major Pharmaceuticals

Variants: 100 mg, 10 capsules (10x1) per bag

Lot Numbers:

M05205A (Exp 10/2026)

M05205B (Exp 10/2026)

NDC:

55154-3363-0

Distributed by Cardinal Health; Recall #: D-0508-2025; Quantity: 3,527 bags