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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Major Pharmaceuticals Ziprasidone Capsules Recalled for Containing Dronabinol

Agency Publication Date: June 16, 2023
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Summary

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has recalled one lot of Ziprasidone Hydrochloride Capsules (20 mg) because the cartons may actually contain Dronabinol Capsules (2.5 mg) due to a labeling mix-up. This recall affects unit dose cartons containing 40 capsules. No incidents or injuries have been reported to date regarding this mix-up.

Risk

Taking the wrong medication can lead to serious adverse health effects. Ziprasidone is used to treat schizophrenia and bipolar disorder, while Dronabinol is a synthetic cannabinoid; taking the incorrect drug may lead to ineffective treatment of the primary condition or unexpected side effects and drug interactions.

What You Should Do

  1. The recalled product is Major Pharmaceuticals Ziprasidone Hydrochloride Capsules (20 mg) sold in 40-count unit dose cartons with NDC 0904-6269-08, lot number T04769, and an expiration date of 12/2024.
  2. If you have health concerns or believe you have taken the wrong medication, contact your healthcare provider or pharmacist immediately.
  3. Return any unused capsules to the place of purchase for a refund, throw them away, or contact the manufacturer directly for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

💰Option 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
🗑️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: Ziprasidone Hydrochloride Capsules (20 mg)by Major Pharmaceuticals
Variants: 20 mg, Unit Dose Carton 40 Capsules
UPC Codes:
309046269083
Lot Numbers:
T04769 (Exp. 2024/12)
NDC:
0904-6269-08

Cartons labeled as Ziprasidone may contain Dronabinol Capsules USP, 2.5 mg.

Product Images

Image 1, Carton Label for Dronabinol Capsules, USP, 2.5 mg

Image 1, Carton Label for Dronabinol Capsules, USP, 2.5 mg

Image 2, Carton Label for Ziprasidone Hydrochloride Capsules, USP, 20 mg

Image 2, Carton Label for Ziprasidone Hydrochloride Capsules, USP, 20 mg

Image 3, Blister Packaging Label for Dronabinol Capsules, USP, 2.5 mg

Image 3, Blister Packaging Label for Dronabinol Capsules, USP, 2.5 mg

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92463
Status: Resolved
Manufacturer: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: unknown
Distributed To: Nationwide
Agency Last Updated: July 5, 2023

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 · FDA Press Release · 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.