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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 Failed Dissolution Specifications

Agency Publication Date: June 25, 2024
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Summary

Pacira Pharmaceuticals Inc. is recalling 40,517 kits of Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial. The recall was initiated because the product failed dissolution testing, meaning the medication might not release at the correct rate into the body as intended. This specific lot of the prescription medication was distributed nationwide across the United States.

Risk

If the medication fails to meet dissolution specifications, it may not provide the expected long-term pain relief for patients or could potentially cause localized irritation at the injection site. No injuries or adverse health events have been reported to date.

What You Should Do

  1. This recall affects Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial kits from lot 23-9006 with an expiration date of March 2025.
  2. Stop using the recalled medication immediately and quarantine any remaining stock.
  3. If you have health concerns or believe you have received an injection from this recalled lot, contact your healthcare provider or pharmacist.
  4. Contact Pacira Pharmaceuticals Inc. or your distributor to arrange for the return of any unused product from this lot.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and return product.

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)
Variants: 32 mg per vial, Injectable suspension
Lot Numbers:
23-9006 (Exp MAR 2025)
NDC:
65250-003-01
65250-001-01
65250-002-01

Affected kit includes 5 mL sterile single-use vial of diluent.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94791
Status: Active
Manufacturer: PACIRA PHARMACEUTICALS INC
Manufactured In: United States
Units Affected: 40,517 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 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.