CLASS III Drug recall · Reported 14 Feb 2018 · FDA Enforcement Report
Ciclopirox Olamine Cream recalled by G & W Laboratories
G & W Laboratories is recalling Ciclopirox Olamine Cream USP, 0.77%, distributed nationwide in the US. The recall was initiated on 19 Jan 2018 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-0250-2018
- FDA event ID
- 78974
- Recalling firm
- G & W Laboratories, South Plainfield, NJ
- Brand
- Ciclopirox Olamine
- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Jan 2018
- FDA classified
- 2 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 19 Jan 2018 | Recall initiated by company | |
| 2 Feb 2018 | Classified by FDA | +14 days |
| 14 Feb 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Which lots are affected?
Lot #: a) 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19; b) 1002561, Exp 06/18; 1002897, Exp 09/18; 1005798, Exp 05/19; 1006101, Exp 07/19; c) 1002898, Exp 10/18; 1004283, Exp 12/18; 1005837, Exp 05/19; 1006321, 1006322, Exp 07/19
Where was it sold?
Nationwide in the USA and Puerto Rico
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 G & W Laboratories
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | G & W Clobetasol Propionate Ointment recalled by G & W LaboratoriesClobetasol Propionate | G & W Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Ciclopirox Olamine Cream recalled by G & W LaboratoriesCiclopirox Olamine | G & W Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS III | Clindamycin Phosphate Topical Solution recalled by G & W Laboratories | G & W Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips recalled | G & W Laboratories | Potency & Assay | NJ |
| Drug | CLASS III | G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm recalledFluocinolone Acetonide | G & W Laboratories | Other | Nationwide |
Other Ciclopirox Olamine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Ciclopirox Olamine Cream recalled by G & W LaboratoriesCiclopirox Olamine | G & W Laboratories | Packaging Defects | Nationwide |