Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported July 8, 2020
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
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Flexion Therapeutics, Inc. recalled Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial,… - a low-severity action.
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial,… was recalled by Flexion Therapeutics, Inc. in July 8, 2020. Reason: Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distribut…. Check the official notice for the remedy. Verify recall #D-1376-2020 with the FDA Drug before acting.
The recall
Flexion Therapeutics, Inc. issued this low-severity FDA Drug recall-Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distribut….
- Low
- severity level
- Class III
- classification
- July 8, 2020
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1376-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1376-2020) was formally reported on July 8, 2020, with the manufacturer initiating the action on May 19, 2020. It is classified under Low severity (Class III), with a current status of Terminated. Flexion Therapeutics, Inc. is listed as the recalling firm, operating out of Burlington, MA. Federal records list the affected scope as 792 kits.
The documented reason for this recall is: Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded Distribution data in the federal record shows the product reached: Nationwide within the United States only lots distributed by Besse Medical are affected.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
792 kits
Related Recalls
6
5 from same agency
Product description
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
Reason for recall
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1376-2020 |
| Date reported | July 8, 2020 |
| Date initiated | May 19, 2020 |
| Recalling firm | Flexion Therapeutics, Inc. |
| Firm location | Burlington, MA |
| Affected scope | 792 kits |
| Distribution | Nationwide within the United States only lots distributed by Besse Medical are affected. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1376-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Flexion Therapeutics, Inc.. Units affected: 792 kits.
Why was this product recalled? ▼
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 8, 2020. Severity: Low. Recall number: D-1376-2020.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the United States only lots distributed by Besse Medical are affected..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1376-2020) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
FDA Drug Low
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie c…
AbbVie Inc. · 2026-06-03
FDA Food Moderate
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Amber PET modern round 24-400 bot…
Llorens Pharmaceuticals International Division, Inc. · 2026-05-27
FDA Drug Moderate
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by:…
Safecor Health, LLC · 2026-05-27
FDA Drug Moderate
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
IntegraDose Compounding Services LLC · 2026-05-27
FDA Drug Moderate
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, …
Lupin Pharmaceuticals Inc. · 2026-05-27
Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 8, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.