Coppertone SUNSCREEN LOTION — Class II drug recall D-0977-2016
Terminated recall by Bayer Health Care LLC, reported 2016-06-15, distributed nationwide. Labeling; Product Contains Undeclared API (Oxybenzone)
| Recall number | D-0977-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Health Care LLC, Cleveland, TN, United States |
| Recall initiated | 2016-05-10 |
| Classified | 2016-06-09 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2016-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 37,512 bottles |
| Reason classes | undeclared allergen, labeling |
| UPC / GTIN / UDI-DI | 00041100005762 |
| NDC | 11523-7391-01 |
Product
Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762
Reason for recall
Labeling; Product Contains Undeclared API (Oxybenzone)
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-0977-2016. 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.