Lower risk Drug recall · FDA · Published May 19, 2020

Flexion Ther: Zilretta 32mg vials recalled due to temperature abuse risk

Flexion Therapeutics recalls Zilretta 32mg vials (lot ZA19014) that were stored longer than 6 weeks at room temperature, posing a temperature abuse risk. Affected units were distributed by Besse Medical.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1376-2020Drug Flexion Therapeutics ›

Lower-risk recall

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

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Contact the company

Recalling firmFlexion Therapeutics, Inc.10 Mall Rd Ste 301 · Burlington, MA 01803-4121

✎ GovInfoNow plain-language explainer

Flexion Therapeutics has recalled Zilretta 32mg per vial injectable suspensions that were stored at room temperature for more than 6 weeks. This could lead to improper drug stability and potential safety issues if used. Read more at govinfonow.com/recall/37113-flexion-ther-zilretta-32mg-vials-recalled-due-to-temperature-abuse.

Source Summary by GovInfoNow · govinfonow.com/recall/37113-flexion-ther-zilretta-32mg-vials-recalled-due-to-temperature-abuse · Updated October 5, 2026 · FDA enforcement record: FDA #D-1376-2020

Cite this page

“Flexion Ther: Zilretta 32mg vials recalled due to temperature abuse risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37113-flexion-ther-zilretta-32mg-vials-recalled-due-to-temperature-abuse. Based on FDA recall #D-1376-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1376-2020%22&limit=1).

The FDA announced on May 19, 2020, that Flexion Therapeutics, Inc. voluntarily recalled Zilretta single-dose kits due to temperature abuse risks. The agency issued recall number D-1376-2020 for the Class III drug.

How to tell if you have it

Brand: Flexion Therapeutics
Product: Zilretta (triamcinolone acetonide extended-release injectable suspension)
Strength/Size: 32mg per vial, 5mL vials
NDC: 70801-003-01
Lot #: ZA19014
Expiration date: 05/2021
Distribution: Nationwide within the United States, only lots distributed by Besse Medical

The hazard

The product was stored at room temperature longer than six weeks and was inadvertently distributed instead of being discarded. The recall involves 792 kits.

Context

GovInfoNow's records show other recent recalls of similar products include McKesson Recalls UDENYCA Injection Due to Temperature Abuse Risk (2026-01-16), McKesson Gemcitabine Injection Recall: Temperature Storage Risk (2026-06-10), and TerSera Recalls Zoladex Implants Due to Temperature Abuse (2026-08-31).

How to tell if you have this one

Check for Zilretta 32mg per vial (5mL) single-dose kits with lot number ZA19014. Only units distributed by Besse Medical are affected.

Brand
Flexion Therapeutics
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the lot number on the vial; affected units have lot ZA19014 distributed by Besse Medical.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States only lots distributed by Besse Medical are affected.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 6 months after the firm started it.

May 19, 2020Firm started the recall
Jul 8, 2020FDA classified it Class III
Jul 8, 2020Published in FDA’s Enforcement Report
Nov 3, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/37113-flexion-ther-zilretta-32mg-vials-recalled-due-to-temperature-abuse">Flexion Ther: Zilretta 32mg vials recalled due to temperature abuse risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1376-2020 (May 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1376-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.