Health-Tec — Class II drug recall D-0142-2025
Terminated recall by Keystone Industries, reported 2024-12-25, distributed nationwide. CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vess
| Recall number | D-0142-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Industries, Gibbstown, NJ, United States |
| Recall initiated | 2024-11-14 |
| Classified | 2024-12-13 |
| Reported by FDA | 2024-12-25 |
| Terminated | 2026-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DO, HN, QA, SV |
| Reason classes | cgmp |
| NDC | 69634-0021, 69634-0021-30 |
| Lot numbers | BNZ-001646 |
| Model numbers | 03-28119 |
| Expiration dates | 2026-11-26 |
Product
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
Reason for recall
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
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-0142-2025. 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.