# FDA recall D-0489-2023

> **Azurity Pharmaceuticals, Inc.** · Class II · drug recall initiated 2023-02-15.

## Product

Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.

## Reason for recall

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

## Distribution

US Nationwide

## Key facts

- **Recall number:** D-0489-2023
- **Recalling firm:** Azurity Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-02-15
- **Report date:** 2023-04-12
- **Termination date:** 2023-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wilmington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0489-2023

## Citation

> AI Analytics. FDA recall D-0489-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0489-2023. Source: US FDA. Licensed CC0.

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