CeraVe Healing Lip Balm/SPF 30 — Class II drug recall D-0071-2019
Terminated recall by Product Quest Manufacturing LLC, reported 2018-10-24, distributed nationwide. Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
| Recall number | D-0071-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Product Quest Manufacturing LLC, Daytona Beach, FL, United States |
| Recall initiated | 2018-08-03 |
| Classified | 2018-10-16 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2021-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 25,596 sticks |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00301872492017 |
| Lot numbers | PSP85W/172792H |
Product
CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.
Reason for recall
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
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-0071-2019. 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.