Ciclopirox shampoo 1% — Class III drug recall D-0512-2019
Terminated recall by Perrigo New York, Inc., reported 2019-02-27, distributed nationwide. Failed Degradation/Impurities Specifications: Out of specification related substance results during stability
| Recall number | D-0512-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perrigo New York, Inc., Bronx, NY, United States |
| Recall initiated | 2019-02-13 |
| Classified | 2019-02-20 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2021-09-08 |
| Distributed | Nationwide (US) |
| Quantity | 12,252 bottles |
| Reason classes | specification failure |
| NDC | 45802-0401, 45802-0401-09 |
| Lot numbers | 02/19, 7DT0280, 7ET0565 |
Product
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
Reason for recall
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
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-0512-2019. 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.