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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Flexion Therapeutics, Inc.: Zilretta Injection Recalled for Temperature Storage Issues

Agency Publication Date: June 26, 2020
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Summary

Flexion Therapeutics is recalling 792 kits of Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial. The medication was stored at room temperature for longer than the recommended six-week limit and was accidentally distributed instead of being destroyed. This drug is an injectable medication used for osteoarthritis pain, and consumers should contact their healthcare provider if they have received treatment from the affected lot.

Risk

The product was exposed to room temperatures for an excessive period, which may affect the stability or effectiveness of the medication. Using medication that has been improperly stored could result in a reduced therapeutic effect for the patient.

What You Should Do

  1. Identify if you have received or possess Zilretta (triamcinolone acetonide) 32mg single-dose kits from Lot Number ZA19014 with an expiration date of 05/2021.
  2. Verify if your medication was distributed by Besse Medical, as only the specific lot distributed through this provider is included in this recall.
  3. If you are a patient who has received an injection from this lot, contact your healthcare provider or pharmacist to discuss your treatment and any concerns regarding the medication's effectiveness.
  4. Healthcare providers should immediately stop using and quarantine any remaining units from Lot ZA19014 (Exp. 05/2021) and contact the manufacturer for return instructions.
  5. Return any unused product from the affected lot to your pharmacy to receive a refund.
  6. Contact Flexion Therapeutics at their Burlington, MA headquarters for further instructions regarding the return process.
  7. For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Guidance and refund for unused medication

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

Affected Products

Product: Zilretta (triamcinolone acetonide extended-release injectable suspension) 32mg per vial (5mL)
Model:
NDC 70801-003-01
Recall #: D-1376-2020
Lot Numbers:
ZA19014 (Exp. 05/2021)
Date Ranges: Expiration date 05/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85742
Status: Resolved
Manufacturer: Flexion Therapeutics, Inc.
Sold By: Besse Medical
Manufactured In: United States
Units Affected: 792 kits
Distributed To: Nationwide
Agency Last Updated: July 23, 2020

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.