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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/Over-the-Counter

Contract Pharmacal Corporation: Extra Strength Acetaminophen Recalled for Potential Prenatal Tablet Contamination

Agency Publication Date: February 14, 2020
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Summary

Contract Pharmacal Corporation is recalling approximately 12,864 bottles of Leader and Major brand Extra Strength Acetaminophen (500 mg) tablets. This recall was initiated after a report that a single Women’s Prenatal dietary supplement tablet was found mixed into a 1000-count bottle of the pain reliever. Consumers may unknowingly ingest a medication or supplement they were not intended to take, which could lead to health complications or drug interactions. These products were sold in 100-count and 1000-count bottles across the United States.

Risk

If a consumer accidentally ingests the foreign prenatal dietary supplement instead of the intended acetaminophen, they may experience adverse health effects or interactions with other medications they are currently taking.

What You Should Do

  1. Check your medicine cabinet for Leader or Major brand Extra Strength Acetaminophen 500 mg tablets in 100-count or 1000-count bottles.
  2. Identify if your bottle is affected by looking for Lot Number 193005 with an Expiration Date of 08/21.
  3. Verify the UPC codes on the packaging: Leader 100-count (UPC 096295138078), Major 100-count (UPC 309046730606), or Major 1000-count (UPC 309046730804).
  4. If your bottle matches these identifiers, stop using the product immediately to avoid the risk of consuming the incorrect tablet.
  5. Contact your healthcare provider or pharmacist for guidance. Return any unused product to the place of purchase for a refund and contact Contract Pharmacal Corporation for further instructions.
  6. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: Leader Extra Strength Acetaminophen Tablets, 500 mg (100-count)
Model:
NDC 7000-0036-1
UPC Codes:
096295138078
Lot Numbers:
193005 (Exp. 08/21)
Date Ranges: Expiration Date 08/21
Product: Major Extra Strength Acetaminophen Tablets, 500 mg (100-count)
Model:
NDC 0904-6730-60
UPC Codes:
309046730606
Lot Numbers:
193005 (Exp. 08/21)
Date Ranges: Expiration Date 08/21
Product: Major Extra Strength Acetaminophen Tablets, 500 mg (1000-count)
Model:
NDC 0904-6730-80
UPC Codes:
309046730804
Lot Numbers:
193005 (Exp. 08/21)
Date Ranges: Expiration Date 08/21

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84857
Status: Resolved
Manufacturer: Contract Pharmacal Corporation
Sold By: Cardinal Health; Major Pharmaceuticals
Manufactured In: United States
Units Affected: 2 products (5472 bottles; a) 1176 bottles b) 6,216 bottles)
Distributed To: Nationwide
Agency Last Updated: February 27, 2020

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 · 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.