Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Zilretta (triamcinolone acetonide extended-release injectable suspension) Recalled by Flexion Therapeutics, Inc. Due to Temperature Abuse: Product was stored at room temperature...

Date: May 19, 2020
Company: Flexion Therapeutics, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Flexion Therapeutics, Inc. directly.

Affected Products

Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01

Quantity: 792 kits

Why Was This Recalled?

Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Flexion Therapeutics, Inc.

Flexion Therapeutics, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report