# FDA recall D-0530-2026

> **Huons Co., Ltd.** · Class II · drug recall initiated 2026-04-02.

## Product

Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule),  NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)

## Reason for recall

Lack of Assurance of Sterility

## Distribution

USA Nationwide.

## Key facts

- **Recall number:** D-0530-2026
- **Recalling firm:** Huons Co., Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-02
- **Report date:** 2026-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jecheon, N/A, Korea (the Republic of)

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0530-2026

## Citation

> AI Analytics. FDA recall D-0530-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0530-2026. Source: US FDA. Licensed CC0.

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