Key facts
| Recalling firm | Huons Co., Ltd. |
|---|---|
| Manufacturer | Huons Co., Ltd. |
| Brand name | LIDOCAINE HYDROCHLORIDE |
| Product description | Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton) |
| Classification | Class II |
| Recall number | D-0532-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Lack of Assurance of Sterility |
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield (additional items listed in FDA's full record) -- and the recall number D-0532-2026. If it matches, stop using or distributing it and contact Huons Co., Ltd. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Huons Co., Ltd. and the affected product is described in FDA's record as: Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield (additional items listed in FDA's full record). FDA's stated reason for the recall is: Lack of Assurance of Sterility. The recall is tracked under FDA recall number D-0532-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.
Huons Co., Ltd.’s FDA history
Argus HQ has recorded 5 total FDA actions tied to Huons Co., Ltd.: 1 warning letter, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield (additional items listed in FDA's full record)) and.
- Has Huons Co., Ltd. had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 5 total FDA actions tied to Huons Co., Ltd., including 4 recalls and 1 warning letter.
- What is the FDA recall number for this event?
- FDA recall number D-0532-2026.
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Related enforcement actions
Full FDA history for Huons Co., Ltd.Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class II Recall: LIDOCAINE HYDROCHLORIDE by Huons Co., Ltd. — Recall Details. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-huons-co-ltd-d-0532-2026
"FDA Class II Recall: LIDOCAINE HYDROCHLORIDE by Huons Co., Ltd. — Recall Details." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-huons-co-ltd-d-0532-2026.
Argus HQ Research. "FDA Class II Recall: LIDOCAINE HYDROCHLORIDE by Huons Co., Ltd. — Recall Details." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-huons-co-ltd-d-0532-2026.
@misc{argushq_argushq_ai_recall_fda_recall_huons_co_ltd_d_0532_2026_2026,
title = {FDA Class II Recall: LIDOCAINE HYDROCHLORIDE by Huons Co., Ltd. — Recall Details},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-huons-co-ltd-d-0532-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗