Orajel Cold Sore Pain Cream Recalled for Improper Storage Conditions
Orajel Cold Sore Pain Cream 1.25 fl. oz. was recalled because it was stored outside appropriate temperature conditions. The product was distributed to Family Dollar Stores from April 30 through June 10, 2022.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing control deviation affecting storage conditions that could impact product quality and efficacy, but this is a precautionary recall with no documented adverse events.
Plain-English summary
Orajel Cold Sore Pain Cream 1.25 fl. oz. is being recalled. The product was distributed to specific Family Dollar Stores from April 30, 2022 through June 10, 2022. The affected product has SKU 906766.
The recall was initiated because the product was held outside appropriate storage temperature conditions. This manufacturing control deviation violates CGMP (Current Good Manufacturing Practice) requirements and could affect product quality and efficacy.
Consumers who purchased this product from Family Dollar Stores during the distribution period may have been affected.
Consumers should not use this product and should contact Family Dollar or the manufacturer with questions. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Orajel Cold Sore Pain Cream 1.25 fl. oz. distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug — Topical Pain Cream
- Hazard
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)
- SKU: 906766
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by Family Dollar Stores, Llc. 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.
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