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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

Park Avenue Compounding Phenylephrine HCI Recalled for Quality Deviations

Agency Publication Date: December 2, 2025
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Summary

Park Avenue Compounding is recalling 858 syringes of Phenylephrine HCI (1000 mcg / 10 mL) due to deviations from Current Good Manufacturing Practice (CGMP) requirements. These injectable syringes were distributed in Missouri and were found to have quality control issues that could affect the safety and effectiveness of the medication. Consumers and healthcare facilities should immediately identify and isolate the affected lot to prevent further use.

Risk

Failure to follow proper manufacturing practices for injectable drugs can lead to potential sterility issues or incorrect potency, which may cause serious health complications for patients receiving the medication.

What You Should Do

  1. Check your medication to see if it is Phenylephrine HCI, 1000 mcg / 10 mL in a 10 mL syringe with NDC 83863-0104-1.
  2. Locate the lot number and expiration date on the syringe label; this recall only affects Lot # 20250813-13D65E with an expiration date of FEB-09-2026.
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer, Park Avenue Compounding, or your distributor to arrange for the return of any unused syringes.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

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: Phenylephrine HCI, 1000 mcg / 10 mL (10 mL syringe)by Park Avenue Compounding
Variants: Rx Only, Injectable Syringe
Lot Numbers:
20250813-13D65E (Exp FEB-09-2026)
NDC:
83863-0104-1

Quantity: 858 syringes affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97960
Status: Active
Manufacturer: Park Avenue Compounding
Sold By: Clinical/Hospital Distribution
Manufactured In: United States
Units Affected: 858 syringes
Distributed To: Missouri

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.