Accucaine — Class II drug recall D-0658-2026
Ongoing recall by Asclemed USA Inc., reported 2026-07-08, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0658-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Asclemed USA Inc., Torrance, CA, United States |
| Recall initiated | 2026-06-08 |
| Classified | 2026-07-02 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 76420-0715, 76420-0715-01 |
| Lot numbers | 010626X3, 022525X4, 030426X2, 033125X1, 033125X2, 041326X4, 041426X2, 041725X3, 041726X1, 051826X2, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 121924X2, 122225X4, AE3102, AE5052 |
| Expiration dates | 2026-11-30, 2028-04-30 |
Product
Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.
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-0658-2026. 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.