Pacira Pharmaceuticals Recalls Zilretta Injectable Suspension for Failed Dissolution Testing
Pacira Pharmaceuticals recalls Zilretta intra-articular injectable suspension nationwide after the product failed dissolution specifications in stability testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with failed dissolution specifications indicating formulation instability. The product failed quality testing and poses a potential risk of therapeutic failure or unknown medication stability. No reported illnesses or injuries are documented. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pacira Pharmaceuticals has recalled Zilretta (triamcinolone acetonide extended-release injectable suspension), a corticosteroid medication administered by intra-articular joint injection. The affected product consists of 40,517 kits of 32 mg per vial formulations distributed nationwide.
The recall was initiated because the product failed to meet dissolution specifications during stability testing. Batches from Lot 23-9006 did not meet acceptance criteria for IVR Level 3 testing conducted after nine months of storage at 2-8°C followed by six weeks at 25°C. This indicates the drug formulation may not properly dissolve or release the active ingredient under these conditions.
The recalled product is limited to Lot 23-9006 with an expiration date of March 2025. Patients and healthcare providers with this product should contact Pacira Pharmaceuticals for more information regarding this recall and appropriate follow-up measures.
The recalled product
- Product
- ZILRETTA (TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION)
- Brand
- ZILRETTA
- Manufacturer
- PACIRA PHARMACEUTICALS INC
- Category
- Drug
- Affected units
- 40,517
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 23-9006
- Expiry Date: MAR 2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ZILRETTA
- HighZilretta Injectable Drug Recalled for Failed Stability Specifications
FDA (Drugs) · 2024-06-19
Same manufacturer · PACIRA PHARMACEUTICALS INC
See all →- ModeratePacira Recalls Sub-Potent Exparel Bupivacaine Injectable Vials
FDA (Drugs) · 2019-12-11
- SeverePacira Recalls Subpotent EXPAREL Bupivacaine Injectable Vials
FDA (Drugs) · 2013-03-06
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
- ModerateChlorthalidone 25mg tablets failed dissolution specifications in two batches
FDA (Drugs) · 2026-06-24
- ModerateNiacin extended-release tablets failed dissolution testing at 24 hours
FDA (Drugs) · 2026-06-17
- ModerateMinocycline extended-release tablets failed dissolution testing during stability analysis
FDA (Drugs) · 2026-06-17