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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: Children's Acetaminophen and Diphenhydramine Recalled for Bacterial Contamination

Agency Publication Date: June 27, 2019
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Summary

H J Harkins Company Inc (Pharma Pac) is recalling approximately 52 bottles of Children's Acetaminophen Liquid (160 mg/5 mL) and Diphenhydramine HCL Liquid (12.5 mg/5 mL) due to potential contamination with bacteria. The affected products include 4 oz bottles of Acetaminophen and 4 oz bottles of Diphenhydramine manufactured by Torrent Pharma. The recall was initiated because the products may contain Burkholderia cepacia and Ralstonia pickettii, which can cause serious infections. These medications were distributed nationwide across the United States.

Risk

The potential presence of Burkholderia cepacia and Ralstonia pickettii in these liquid medications poses a significant health risk, especially to children and individuals with weakened immune systems. These bacteria can lead to severe, life-threatening respiratory infections or other systemic illnesses if ingested or used.

What You Should Do

  1. Check your medicine cabinet for Acetaminophen Children's Liquid (160 mg/5 mL, 4 oz bottle) with NDC 52959-0309-04 and lot numbers ACL75M (Exp. 02/20), ACL76M (Exp. 08/19), or ACL77M (Exp. 05/20).
  2. Check your medicine cabinet for Diphenhydramine HCL Liquid (12.5 mg/5 mL, 4 oz bottle) with NDC 52959-0123-03 and lot number DHI56M (Exp. 12/19).
  3. Immediately stop using these products if you identify any of the affected lot numbers.
  4. Contact your healthcare provider or pharmacist for guidance if you or your child have used these products, and to discuss alternative treatment options.
  5. Return any unused product to the pharmacy or place of purchase for a full refund and contact H J Harkins Company Inc for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Return to place of purchase for refund.

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

Affected Products

Product: Acetaminophen Children's Liquid, 160 mg/5 mL (4 oz)
Model:
NDC 52959-0309-04
Lot Numbers:
ACL75M (Exp. 02/20)
ACL76M (Exp. 08/19)
ACL77M (Exp. 05/20)
Product: Diphenhydramine HCL Liquid, 12.5 mg/5 mL (4 oz)
Model:
NDC 52959-0123-03
Lot Numbers:
DHI56M (Exp. 12/19)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83195
Status: Resolved
Manufacturer: H J Harkins Company Inc dba Pharma Pac
Manufactured In: United States
Units Affected: 2 products (40 bottles; 12 bottles)
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.