G & W Laboratories Recalls Ciclopirox Olamine Cream Due to Outdated Insert
G & W Laboratories is recalling 230,700 tubes of Ciclopirox Olamine Cream because some lots were packaged with an out-of-date package insert.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is limited to packaging documentation (outdated insert) rather than a physical or chemical defect in the drug itself.
Plain-English summary
G & W Laboratories, Inc. is recalling 230,700 tubes of Ciclopirox Olamine Cream USP, 0.77%. The product is available in 15 g, 30 g, and 90 g tubes and is distributed nationwide in the USA and Puerto Rico.
The recall was initiated because specific product lots were packaged with an out-of-date package insert. This is a labeling issue involving incorrect or missing package insert information.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- CICLOPIROX OLAMINE (CICLOPIROX OLAMINE)
- Brand
- CICLOPIROX OLAMINE
- Manufacturer
- G & W Laboratories, Inc.
- Category
- Drug — Topical Antifungal
- Hazard
- Affected units
- 230,700
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #: a) 63800090
- Exp 04/17
- 63800095
- Exp 11/17
- 1000573
- Exp 02/18
- 1002560
- Exp 06/18
- b) 63800090
- 63800092
- Exp 07/17
- 63800093
- Exp 08/17
- 1000574
- 1001772
- Exp 05/18
- c) 63800089
- Exp 03/17
- 63800091
- 63800094
UPCs (1)
- 0307130638159
Distribution
Related recalls
Same brand · CICLOPIROX OLAMINE
- LowG & W Laboratories Recalls Ciclopirox Olamine Cream Due to Discoloration
FDA (Drugs) · 2018-02-14
Same manufacturer · G & W Laboratories, Inc.
See all →- ModerateG & W Clobetasol Propionate Ointment Recalled for Impurity
FDA (Drugs) · 2017-07-12
- LowG&W Laboratories Recalls Clindamycin Phosphate Topical Solution Due to Expired Ingredient
FDA (Drugs) · 2017-03-22
- SevereG&W Laboratories Recalls Indocin Suppositories for Impurity Failures
FDA (Drugs) · 2017-03-08
- LowG & W Fluocinolone Acetonide Cream Recalled for Content Uniformity Failure
FDA (Drugs) · 2014-01-08
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- LowG & W Laboratories Recalls Ciclopirox Olamine Cream Due to Discoloration
FDA (Drugs) · 2018-02-14
- LowWatson Recalls Loxapine Capsules Due to Outdated Patient Outsert Labeling
FDA (Drugs) · 2012-07-11
- ModerateCiclopirox Gel 0.77% Tubes Recalled Due to Broken Seals
FDA (Drugs) · 2024-10-09
- LowWatson Loxapine Capsules Recalled for Outdated Patient Outsert Labeling
FDA (Drugs) · 2012-07-11
- LowTaclonex Topical Suspension Recalled for Outdated Package Insert
FDA (Drugs) · 2017-02-22
- LowWatson Recalls Loxapine Capsules Due to Outdated Patient Outsert
FDA (Drugs) · 2012-07-11