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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Major Pharmaceuticals Gabapentin Capsules Recalled for Impurities

Agency Publication Date: October 17, 2025
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Summary

The Harvard Drug Group LLC is recalling multiple lots of Major Pharmaceuticals Gabapentin Capsules (100 mg) due to the presence of an unknown impurity discovered during routine quality testing. Gabapentin is a prescription medication used to treat seizures and nerve pain. The recall affects both 100-count blister packs and 10-count outer bags distributed nationwide to pharmacies and healthcare facilities. You should consult your doctor or pharmacist if you have concerns about your medication, but do not stop taking it without professional advice.

Risk

Routine stability testing identified an 'out of specification' result for an unknown impurity, meaning the drug may degrade or contain substances above the safety limits established by the FDA. This could potentially reduce the medication's effectiveness or cause unexpected side effects.

What You Should Do

  1. Identify your medication by checking for Gabapentin Capsules (100 mg) in 10-count or 100-count blister packs under the brand Major Pharmaceuticals.
  2. Check the lot numbers and expiration dates on your packaging. Affected lots include M04950, M04989, M04990, M05056, M05150, M05290, M05312, M05342, M05369, and M05386 with expiration dates ranging from January 2026 to February 2027. See the Affected Products section below for the full list of affected codes.
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 (10 x 10 blister packs)by Major Pharmaceuticals
Variants: 100 mg
Lot Numbers:
M04950 (Exp 01/2026)
M04989 (Exp 02/2026)
M04990 (Exp 02/2026)
M05056 (Exp 04/2026)
M05150 (Exp 07/2026)
M05290 (Exp 11/2026)
M05312 (Exp 01/2027)
M05342 (Exp 01/2027)
M05369 (Exp 02/2027)
M05386 (Exp 02/2027)
NDC:
0904-6665-61

Rx only; Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268

Product: Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack)by Major Pharmaceuticals
Variants: 100 mg
Lot Numbers:
M04989A [Bag] (Exp 02/2026)
M04989 [Blister Pack] (Exp 02/2026)
M05056A [Bag] (Exp 04/2026)
M05056 [Blister Pack] (Exp 04/2026)
M05150A [Bag] (Exp 07/2026)
M05150 [Blister Pack] (Exp 07/2026)
M05312A [Bag] (Exp 01/2027)
M05312 [Blister Pack] (Exp 01/2027)
M05342A [Bag] (Exp 01/2027)
M05342 [Blister Pack] (Exp 01/2027)
NDC:
0904-6665-61
55154-3363-0

Blister pack NDC 0904-6665-61; Outer Bag NDC 55154-3363-0

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97777
Status: Active
Manufacturer: The Harvard Drug Group LLC
Sold By: pharmacies; healthcare facilities
Manufactured In: United States
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 ยท 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.