The Recall Desk
ModerateFDA (Drugs)·D-1382-2022·Announced 2022-08-31

Orajel Non Med Teething Gel Recalled for Improper Storage Conditions

Orajel Non Med Teething Gel 0.125 oz is being recalled by Family Dollar Stores due to products being held outside appropriate storage temperature conditions. No illnesses have been reported.

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 due to CGMP deviation in storage temperature. No illnesses or injuries reported. Manufacturing deviation without reported harm and no specific identified hazard justifies a score of 2 (Moderate).

Plain-English summary

Family Dollar Stores, LLC is recalling Orajel Non Med Teething Gel 0.125 oz that was distributed through select Family Dollar Stores from April 30, 2022 through June 10, 2022. The affected products carry SKU 999093 and were distributed nationwide within the United States.

The recall is due to a Current Good Manufacturing Practice (CGMP) deviation. The recalled product was held outside appropriate storage temperature conditions, which could compromise product quality.

No illnesses or injuries have been reported in connection with this recall. Consumers who purchased the product during the stated distribution period should discontinue use. For additional information or concerns regarding this recall, consumers should contact Family Dollar Stores.

The recalled product

Product
ORAJEL NON MED TEETHING GEL 0.125 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Manufacturer
Family Dollar Stores, Llc.
Category
Drug — Teething Gel
Hazard
  • improper-storage

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: 999093

Distribution

Distributed nationwide across the United States.

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