New GPC Inc. Recalls Whitfield Lotion for Labeling Deficiencies
New GPC Inc. is recalling 360 units of Whitfield Lotion in New York because the product lacks required OTC drug listing and labeling.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 and involves labeling and listing deficiencies rather than a direct physical hazard or reported illness, fitting the criteria for moderate severity.
Plain-English summary
New GPC Inc. has initiated a recall of 360 units of Whitfield Lotion, 60 mL, manufactured in Guyana. The product was distributed in New York under batch number 308289.
The recall was issued because the product does not meet monograph requirements. Specifically, the items lack a drug listing, fail to meet Over-the-Counter (OTC) drug labeling requirements, and are labeled as "Not Approved for sale in U.S.A."
Consumers who possess this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
- Manufacturer
- New Gpc Inc.
- Category
- Drug — Over-the-Counter
- Affected units
- 360
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 (1)
- Batch Numbers: 308289
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by New Gpc Inc. 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 7 products in this recall →Related recalls
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