HIGH

Gabapentin 100 mg Capsules Recalled by Major Pharmaceuticals in 2025, 100-Count Pack

Major Pharmaceuticals recalled Gabapentin capsules, 100 mg, 100-count, distributed nationwide in the United States. The recall stems from an out-of-spec highest unknown impurity found during stability testing. Healthcare providers and patients should stop using the product and contact The Harvard Drug Group LLC for guidance.

Quick Facts at a Glance

Recall Date
October 10, 2025
Hazard Level
HIGH
Brands
Gabapentin, Major Pharmaceuticals
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL, ELDERLY, PREGNANT

Hazard Information

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

What You Should Do

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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About This Product

Gabapentin is used to treat nerve pain and seizures. This recall concerns a 100 mg capsule package containing 100 capsules (10 x 10 blister packs).

Why This Is Dangerous

An unknown impurity detected during stability testing may pose health risks. The exact hazard from the impurity is not specified in the recall notice.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Patients using this product should stop taking it and consult a healthcare provider. Pharmacies and clinics may need to substitute with alternative therapies as guided by clinicians.

Practical Guidance

How to identify if yours is affected

  1. Check label for NDC 0904-6665-61
  2. Review lot numbers listed in the recall note (M04950, M04989, M04990, M05056, M05150, M05290, M05312, M05342, M05369, M05386)
  3. Compare expiration dates (01/2026, 02/2026, 04/2026, 07/2026, 11/2026, 01/2027, 02/2027)
  4. If affected, stop use immediately and contact the remedy provider for instructions

Where to find product info

NDC 0904-6665-61 on packaging; Lot numbers and Exp dates printed on blister packs; FDA recall page for D-0030-2026

What timeline to expect

Recall processing and replacement guidance will be provided by The Harvard Drug Group LLC. No specific refund timeline is published.

If the manufacturer is unresponsive

  • File a consumer complaint with the FDA if the company is unresponsive.
  • Keep records of all communications and recall notices.

How to prevent similar issues

  • Verify NDC numbers before dispensing or purchasing prescription medications.
  • Consult a pharmacist if a product appears suspect.
  • Ask healthcare providers about manufacturers and lot-level recalls.
  • Only use prescribed meds from verified pharmacies and follow storage directions.

Documentation advice

Retain the recall notice, bottle label, lot numbers, expiration dates, and all communications with the supplier or healthcare provider.

Product Details

Product: Gabapentin Capsules, USP, 100 mg, 100 capsules (10 x 10 blister packs). Packaged by: Major Pharmaceuticals, Indianapolis, IN 46268, USA. NDC: 0904-6665-61. Sold as: Rx only. Distribution: US nationwide. Brand: Gabapentin. Generic: GABAPENTIN. Lot and expiration data reflect active lots listed below. Observed lots and expirations include M04950 (Exp 01/2026), M04989, M04990 (Exp 02/2026), M05056 (Exp 04/2026), M05150 (Exp 07/2026), M05290 (Exp 11/2026), M05312, M05342, M05369 (Exp 02/2027), M05386 (Exp 02/2027).

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • NDC 0904-6665-61
  • 100 mg strength
  • 100 capsules per package (10 x 10 blister packs)
  • Active lots include M04950, M04989, M04990, M05056, M05150, M05290, M05312, M05342, M05369, M05386
  • Expirations: 01/2026, 02/2026, 04/2026, 07/2026, 11/2026, 01/2027, 02/2027
  • Hazard level: HIGH
View Original Recall on FDA - Drug Safety

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALELDERLYPREGNANT
Injury Types
POISONINGOTHER

Product Classification

Product TypeGabapentin Capsules
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot M04950 Exp 01/2026
Lot M04989
Lot M04990 Exp 02/2026
Lot M05056 Exp 04/2026
Lot M05150 Exp 07/2026
+5 more
UPC Codes
0904-6665
0904-6666
0904-6667
+3 more
Affected States
ALL
Report Date
October 29, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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