Zilretta Injection (Flexion) – Temperature Abuse (2020)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Flexion Therapeutics, Inc.
Lot Codes / Batch Numbers
Lot #: ZA19014, exp. date 05/2021 Only the specific lot distributed by Besse Medical are affected.
Products Sold
Lot #: ZA19014, exp. date 05/2021 Only the specific lot distributed by Besse Medical are affected.
Flexion Therapeutics, Inc. is recalling Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, due to Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026