CLASS III Drug recall · Reported 27 Feb 2019 · FDA Enforcement Report
Ciclopirox shampoo recalled by Perrigo New York
Perrigo New York is recalling Ciclopirox shampoo 1%, distributed nationwide in the US. The recall was initiated on 13 Feb 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0512-2019
- FDA event ID
- 82127
- Recalling firm
- Perrigo New York, Bronx, NY
- Brand
- Ciclopirox
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Feb 2019
- FDA classified
- 20 Feb 2019
- Reported
- 27 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Sunscreen & Personal Care
Timeline
| 13 Feb 2019 | Recall initiated by company | |
| 20 Feb 2019 | Classified by FDA | +7 days |
| 27 Feb 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Which lots are affected?
Lot #: 7DT0280, 7ET0565, Exp. 02/19
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Perrigo New York
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocortisone Ointment recalled by Perrigo New YorkHydrocortisone | Perrigo New York | Potency & Assay | Nationwide |
Other Ciclopirox recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Ciclopirox Shampoo recalled by Taro Pharmaceuticals U.S.ACiclopirox | Taro Pharmaceuticals U | Potency & Assay | Nationwide |