Cortaid 12-Hour Advanced Anti-itch Cream — Class II drug recall D-0086-2019
Terminated recall by Valeant Pharmaceuticals North America LLC, reported 2018-10-31, distributed nationwide. CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral
| Recall number | D-0086-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, United States |
| Recall initiated | 2018-08-24 |
| Classified | 2018-10-22 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2020-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 5,016 tubes |
| Reason classes | microbial contamination, cgmp |
| UPC / GTIN / UDI-DI | 00301875519155 |
| Lot numbers | 172185F, 6/19 |
Product
Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155
Reason for recall
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
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-0086-2019. 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.