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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/Prescription Drugs

Precision Dose Acetaminophen Oral Suspension Recalled for Contamination

Agency Publication Date: November 5, 2021
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Summary

Precision Dose Inc. is recalling 318,020 unit dose cups of Acetaminophen Oral Suspension (160 mg/5 mL and 325 mg/10.15 mL) because they were manufactured with a contaminated raw ingredient. These liquid medications are labeled for hospital use only and were distributed in 30-count and 100-count cases. No injuries or adverse events have been reported to date. Hospitals and healthcare providers should immediately stop using these products and contact the manufacturer to arrange for their return.

Risk

The product was manufactured using a contaminated raw ingredient, which may pose unknown health risks to patients receiving the medication. Contaminated drug products can lead to infection or other systemic health complications, particularly in hospitalized patients with weakened immune systems.

What You Should Do

  1. This recall affects Acetaminophen Oral Suspension (160 mg/5 mL and 325 mg/10.15 mL) unit dose cups packaged under the Precision Dose Inc. brand for hospital use only.
  2. Identify affected 160 mg/5 mL doses by checking for NDC numbers 68094-231-59, 68094-231-62, or 68094-231-61 and lot number 503670.
  3. Identify affected 325 mg/10.15 mL doses by checking for NDC numbers 68094-330-59, 68094-330-62, or 68094-330-61 and lot numbers 503679, 503693, or 503715.
  4. Stop using the recalled product immediately.
  5. Contact Precision Dose Inc. or your distributor to arrange for the return of any remaining inventory.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have further questions or need to report an issue.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Acetaminophen Oral Suspension, 160 mg/5 mLby Precision Dose Inc.
Variants: 5 mL unit dose cup, 30-count case, 100-count case
Lot Numbers:
503670
NDC:
68094-231-59
68094-231-62
68094-231-61

Hospital Use Only. Packaged in 5 mL per cup.

Product: Acetaminophen Oral Suspension, 325 mg/10.15 mLby Precision Dose Inc.
Variants: 10.15 mL unit dose cup, 30-count case, 100-count case
Lot Numbers:
503679
503693
503715
NDC:
68094-330-59
68094-330-62
68094-330-61

Hospital Use Only. Packaged in 10.15 mL per cup.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88976
Status: Resolved
Manufacturer: Precision Dose Inc.
Sold By: Hospitals; Healthcare Providers
Manufactured In: United States
Units Affected: 2 products (166,920 unit dose cups; 151,100 unit dose cups)
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.