Bupivacaine Hydrochloride 0 — Class II drug recall D-0530-2026
Ongoing recall by Huons Co., Ltd., reported 2026-04-22, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0530-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Huons Co., Ltd., Jecheon, N/A, Korea (the Republic of) |
| Recall initiated | 2026-04-02 |
| Classified | 2026-05-15 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 3,260,170 ampules |
| Reason classes | sterility |
| NDC | 71351-0022, 71351-0022-02, 71351-0022-10, 71351-0022-50, 73293-0002, 73293-0002-01, 73293-0002-02 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0530-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.