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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Gabapentin, Major Pharmaceuticals
- Product type
- Gabapentin Capsules
- Model numbers
- Lot M04950 Exp 01/2026, Lot M04989, Lot M04990 Exp 02/2026, Lot M05056 Exp 04/2026, Lot M05150 Exp 07/2026, Lot M05290 Exp 11/2026, Lot M05312, Lot M05342 +2 more
- UPC codes
- 0904-6665, 0904-6666, 0904-6667, 0904-6665-61, 0904-6666-61, 0904-6667-61
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 10, 2025
Reported by FDA DRUG
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check label for NDC 0904-6665-61
- 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.
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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
- 100 capsules per package (10 x 10 blister packs)
- Hazard level: HIGH
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Safety Guide
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