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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Major Pharmaceuticals Gabapentin 600 mg Tablets Recalled for Product Mixup

Agency Publication Date: May 10, 2023
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Summary

The Harvard Drug Group has recalled 3,984 cartons of Gabapentin (gabapentin) Tablets, USP 600 mg distributed by Major Pharmaceuticals and Aurobindo Pharma USA. The recall was issued after a single foreign tablet was discovered in a package, indicating a potential product mixup during packaging. No incidents or injuries have been reported to date. If you have this medication, you should consult with your healthcare provider or pharmacist.

Risk

A product mixup means a patient might inadvertently take a medication other than the one prescribed, which could lead to unexpected side effects or a failure to treat the intended condition. No injuries have been reported in connection with this specific incident.

What You Should Do

  1. The recalled products are Gabapentin Tablets, USP 600 mg (NDC 0904-6823-61) distributed by Major Pharmaceuticals and Aurobindo Pharma USA, Inc. and sold in cartons of 100 tablets (10 blister packs of 10 tablets).
  2. Check your medication packaging for lot number T04468 with an expiration date of 10/2024.
  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 Harvard Drug Group for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have 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 Tablets, USP 600 mg (100 tablets)
Variants: 600 mg, Tablet
Lot Numbers:
T04468 (Exp 10/2024)
NDC:
0904-6823-61

Distributed by Aurobindo Pharma USA, Inc. and Major Pharmaceuticals. Packaged in 10 blister packs of 10 tablets.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92174
Status: Resolved
Manufacturer: The Harvard Drug Group
Sold By: Aurobindo Pharma USA, Inc.; Major Pharmaceuticals
Manufactured In: United States
Units Affected: 3984 cartons
Distributed To: Nationwide

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.