babyganics — Class II drug recall D-0298-2025
Ongoing recall by Johnson, S C and Son, Inc, reported 2025-04-02, distributed nationwide. Failed stability specifications: during routine stability monitoring quality concerns were identified. Physica
| Recall number | D-0298-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Johnson, S C and Son, Inc, Racine, WI, United States |
| Recall initiated | 2025-01-08 |
| Classified | 2025-03-25 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Quantity | 57,184 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00810035921382, 00810035921658 |
| Expiration dates | 2025-10-31, 2026-03-31 |
Product
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
Reason for recall
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
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-0298-2025. 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.