DLC Laboratories Recalls Sulfur Ointment Jars Due to Labeling Error
DLC Laboratories is recalling 86,297 jars of Sulfur Ointment 10% because English labels for Camphor were incorrectly applied to the product.
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, which corresponds to a moderate severity score for minor labeling errors that may cause temporary or medically reversible health consequences.
Plain-English summary
DLC Laboratories, Inc. is recalling 86,297 jars of Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g). The recall is due to a labeling error where English labels with the Drug Facts panel for Camphor were incorrectly placed on the Sulfur Ointment product.
The affected product was distributed nationwide and to Canada, Cambodia, Germany, and the United Kingdom. The recall includes specific lots with expiration dates ranging from May 2023 to August 2023.
Consumers should check their products for the incorrect Camphor labeling. If the product is affected, they should stop using it and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Division of DLC Laboratories, Inc. Paramount, CA 9023 USA; UPC 024286150426
- Manufacturer
- DLC Laboratories, Inc
- Category
- Drug — Topical Ointment
- Hazard
- Affected units
- 86,297
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 (7)
- Lot # 5084
- Exp 05/23
- 5130
- Exp 07/23
- 5132
- 5160
- Exp 08/23.
Distribution
Distributed nationwide across the United States.
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