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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

H J Harkins Company Inc dba Pharma Pac: Acetaminophen Tablets Recalled for Potential Foreign Tablet Contamination

Agency Publication Date: March 12, 2020
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Summary

H J Harkins Company Inc dba Pharma Pac is recalling 11,973 bottles of Extra Strength Acetaminophen (500 mg) tablets because a different product, a Women's Prenatal dietary supplement tablet, was found inside a bottle. This recall affects various bottle sizes, including 30, 42, 45, and 50-count containers. The issue was discovered following a consumer complaint regarding a foreign tablet being commingled with the acetaminophen. Consumers should check their medicine cabinets immediately for the specific lot number listed below to ensure they do not accidentally ingest the wrong medication.

Risk

Ingesting a foreign dietary supplement tablet instead of the intended acetaminophen could lead to unexpected allergic reactions, drug interactions, or the consumption of ingredients that are unsafe for the individual. While only one instance has been reported, the presence of an incorrect pill in a bottle poses a risk of accidental ingestion of the wrong substance.

What You Should Do

  1. Check your bottle of Acetaminophen 500 mg tablets for Lot Number AE00M with an expiration date of 08/2021.
  2. Verify if your bottle is one of the following sizes: 30-count (NDC 52959-0002-30), 42-count (NDC 52959-0002-42), 45-count (NDC 52959-0002-45), or 50-count (NDC 52959-0002-50).
  3. If you identify an affected bottle, stop using the product immediately and look for any tablets that do not match the appearance of the others.
  4. Contact your healthcare provider or pharmacist for guidance regarding your medication needs.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact H J Harkins Company Inc dba Pharma Pac for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Refund and medical consultation.

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

Affected Products

Product: Acetaminophen 500 mg tablet (30-count bottle)
Model:
NDC 52959-0002-30
Lot Numbers:
AE00M (Exp 08/2021)
Product: Acetaminophen 500 mg tablet (42-count bottle)
Model:
NDC 52959-0002-42
Lot Numbers:
AE00M (Exp 08/2021)
Product: Acetaminophen 500 mg tablet (45-count bottle)
Model:
NDC 52959-0002-45
Lot Numbers:
AE00M (Exp 08/2021)
Product: Acetaminophen 500 mg tablet (50-count bottle)
Model:
NDC 52959-0002-50
Lot Numbers:
AE00M (Exp 08/2021)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85158
Status: Resolved
Manufacturer: H J Harkins Company Inc dba Pharma Pac
Manufactured In: United States
Units Affected: 11,973 tablets
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 · 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.