Geritrex Recalls Unapproved Carbo-O-Philic 40 Gel Topical Urea Product
Geritrex Corp is recalling Carbo-O-Philic 40 Gel because the FDA determined it is an unapproved new drug and misbranded.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report specific injuries or illnesses, aligning with a moderate severity rating for regulatory non-compliance without confirmed harm.
Plain-English summary
Geritrex Corp is recalling 1,032 tubes of Carbo-O-Philic 40 Gel 40% (Urea), a prescription-only topical product. The affected units are identified by Lot # 1502078 and 1504139 and were distributed nationwide.
The FDA determined that the product is an unapproved new drug and misbranded because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers and healthcare providers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15
- Manufacturer
- Geritrex Corp
- Category
- Drug — Topical Prescription
- Affected units
- 1,032
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 (2)
- Lot # 1502078
- 1504139
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Geritrex Corp under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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