Advanced Protection Sunscreen spf 30 — Class III drug recall D-0341-2019
Terminated recall by CBI Laboratories, Inc., reported 2018-12-26. Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
| Recall number | D-0341-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CBI Laboratories, Inc., Fort Worth, TX, United States |
| Recall initiated | 2018-12-10 |
| Classified | 2018-12-20 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-01-14 |
| Countries outside the US | AE, CA, NZ |
| Quantity | 5,363 tubes |
| Reason classes | potency, specification failure |
| Lot numbers | 127426, 129045, 130424, 130432, 131870, 131965, 132648, 133732, 134400, 135345 |
| Expiration dates | 2018-12, 2019-01, 2019-06, 2019-10, 2020-02, 2020-03, 2020-04, 2020-08 |
Product
Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
Reason for recall
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
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-0341-2019. 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.