# FDA recall D-0546-2024

> **PACIRA PHARMACEUTICALS INC** · Class II · drug recall initiated 2024-05-07.

## Product

Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01.  Diluent Vial Label: Diluent, 5mL, Sterile single use, Rx only, Manufactured for Pacira Pharmaceuticals Inc., NDC 65250-002-01.  Carton Label: Drug Vial Label: 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.

## Reason for recall

Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.

## Distribution

U.S. Nationwide.

## Key facts

- **Recall number:** D-0546-2024
- **Recalling firm:** PACIRA PHARMACEUTICALS INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-05-07
- **Report date:** 2024-06-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0546-2024

## Citation

> AI Analytics. FDA recall D-0546-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0546-2024. Source: US FDA. Licensed CC0.

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