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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

Zilretta Injectable Suspension Recalled for Stability Testing Failure

Agency Publication Date: June 7, 2024
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Summary

Pacira Pharmaceuticals Inc. is recalling 43,768 kits of Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial. The recall was issued because the medication failed stability testing requirements during long-term refrigerated storage. Zilretta is a prescription injectable medication used to treat osteoarthritis pain in the knee.

Risk

A failure in stability testing means the medication may not maintain its intended strength or quality over time. Using an unstable drug can lead to reduced treatment effectiveness or unexpected side effects.

What You Should Do

  1. This recall affects Zilretta (triamcinolone acetonide extended-release injectable suspension) 32 mg kits with lot number 082657 (kit 23-9004) and an expiration date of July 2024.
  2. Stop using the recalled product immediately.
  3. Contact Pacira Pharmaceuticals Inc. or your medical supply distributor to arrange for the return of any remaining units.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

📋Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Zilretta (triamcinolone acetonide extended-release injectable suspension) 32 mg kit
Variants: 32 mg per vial, Injectable suspension
Model:
23-9004
Lot Numbers:
082657 (Exp: July 2024)
NDC:
65250-001-01
65250-002-01
65250-003-01

Quantity affected: 43,768 kits. Kit includes Drug Vial and Diluent Vial.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94568
Status: Active
Manufacturer: PACIRA PHARMACEUTICALS INC
Sold By: Hospitals; Clinics; Medical distributors
Manufactured In: United States
Units Affected: 43,768 kits
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.