CLASS II ONGOING Drug recall · Reported 3 Jul 2024 · FDA Enforcement Report
Zilretta (triamcinolone acetonide extended-release recalled
Pacira Pharmaceuticals is recalling Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, distributed nationwide in the US. The recall was initiated on 12 Jun 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0567-2024
- FDA event ID
- 94791
- Recalling firm
- Pacira Pharmaceuticals, San Diego, CA
- Brand
- Zilretta
- Manufacturer
- Pacira Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Jun 2024
- FDA classified
- 25 Jun 2024
- Reported
- 3 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Jun 2024 | Recall initiated by company | |
| 25 Jun 2024 | Classified by FDA | +13 days |
| 3 Jul 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd. for: Pacira Pharmaceuticals, Inc. NDC 65250-002-01
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Which lots are affected?
Lot 23-9006; Expiry Date: MAR 2025
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pacira Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Drug Vial Label: Zilretta¿ recalled by Pacira PharmaceuticalsZilretta | Pacira Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Exparel, Bupivicaine Liposome Injectable Suspension recalledExparel | Pacira Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Exparel (bupivacaine liposome injectable suspension) recalled | Pacira Pharmaceuticals | Potency & Assay | Nationwide |
Other Triamcinolone Acetonide recalls
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Triamcinolone Acetonide Cream recalled by Padagis US | Padagis US | Potency & Assay | Nationwide |
| Drug | CLASS II | Drug Vial Label: Zilretta¿ recalled by Pacira PharmaceuticalsZilretta | Pacira Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Triamcinolone Acetonide Injectable Suspension recalled by Eugia USTriamcinolone Acetonide | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS II | Triamcinolone Acetonide cream, 0.1% tube recalled by Direct RxTriamcinolone Acetonide | Direct Rx | Manufacturing (CGMP) Deviations | GA, ID |
| Drug | CLASS II | Triamcinolone Acetonide Cream USP, 0.1% tube recalled by Padagis USTriamcinolone Acetonide | Padagis US | Manufacturing (CGMP) Deviations | Nationwide |