OraLabs Recalls Petroleum Jelly Tubes Due to Undeclared Contaminants
OraLabs is recalling specific lots of petroleum jelly tubes distributed by Rite Aid due to cross-contamination with phenol and camphor.
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 the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
OraLabs, Incorporated is recalling specific lots of petroleum jelly (White Petrolatum) USP 100% tubes. The affected products are distributed by Rite Aid and are available in 1 oz and 2.5 oz tube sizes. The recall covers products with specific lot numbers and expiration dates as identified in the recall notice.
The recall was initiated because of cross-contamination with other products, resulting in the presence of undeclared contaminants, specifically phenol and camphor, in the petroleum jelly tubes. The source text does not report any illnesses or injuries associated with this recall.
Consumers who have purchased these specific lots of petroleum jelly should stop using the product and contact the distributor or manufacturer for further instructions or a refund. The affected products were distributed nationwide within the United States.
The recalled product
- Product
- Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884), b) 2.5 oz tube (UPC 1182298541), Distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011
- Manufacturer
- OraLabs, Incorporated
- Category
- Drug — Topical Ointment
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 (3)
- Lot #: a) 44660922 Exp. 09/22
- b) 44771122
- Exp. 11/22
Distribution
Distributed nationwide across the United States.
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