Quick Facts at a Glance
- Recall Date
- October 10, 2025
- Hazard Level
- HIGH
- Brands
- Gabapentin, Major Pharmaceuticals, Cardinal Health 107 LLC
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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, Cardinal Health 107 LLC
- Product type
- Gabapentin Capsules 100 mg (10 capsules per blister)
- Model numbers
- M04989A, M05056A, M05150A, M05312A, M05342A, NDC 0904-6665-61, NDC 55154-3363-0
- UPC codes
- 0904-6665, 0904-6666, 0904-6667, 55154-3363, 55154-7992, 55154-7993, 0904-6665-61, 0904-6666-61 +4 more
- Sizes
- 10 Capsules per blister pack
- 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 a prescription medication used to treat nerve pain and seizures. This recall involves a 100 mg capsule sold in 10-count blister packs and distributed nationwide in the US.
Why This Is Dangerous
A stability test identified an out-of-spec Highest Unknown Impurity, prompting the recall due to potential safety risk.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
The recall may disrupt treatment for patients currently using these lots. Patients must stop use and consult a healthcare provider for guidance.
Practical Guidance
How to identify if yours is affected
- Review packaging for NDC 0904-6665-61 or 55154-3363-0.
- If affected, stop using immediately and do not dispose through regular trash.
Where to find product info
FDA recall enforcement page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0031-2026
What timeline to expect
Recall does not specify refund/replacement timelines. Typically 4-8 weeks for processing disruptions may occur.
If the manufacturer is unresponsive
- Document all communications with Harvard Drug Group LLC or healthcare providers.
- If the company is unresponsive, contact your pharmacist or local health department for guidance.
- Consider filing a complaint with the FDA recall program if needed.
How to prevent similar issues
- Always verify NDCs, lot numbers, and expiration dates before dispensing medications.
- Consult healthcare providers before switching brands or manufacturers.
- Keep a copy of the recall notice and related packaging for reference.
Documentation advice
Keep the original packaging, lot number, expiration date, purchase receipts if available, and all correspondence with the provider or distributor.
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Product Details
Product: Gabapentin Capsules, USP, 100 mg, 10 capsules per blister pack. Rx only. Distributor: Major Pharmaceuticals, Indianapolis, IN 46268, USA. NDCs: 0904-6665-61 (Blister pack), 55154-3363-0 (Outer Bag). Lot numbers: M04989A, M05056A, M05150A, M05312A, M05342A. Expiration dates: 02/2026, 04/2026, 07/2026, 01/2027. Sold nationwide in the US.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Rx only Gabapentin capsules
- Nationwide US distribution
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Safety Guide
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