Family Dollar Oral Pain Relief Products Recalled for Improper Storage
Family Dollar recalled multiple oral pain relief products due to storage temperature deviations. The products were distributed to select Family Dollar stores from April 30, 2022 through June 10, 2022.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for storage temperature deviations of pharmaceutical products. Improper storage conditions present a potential risk to product integrity and efficacy.
Plain-English summary
Family Dollar Stores is recalling multiple oral pain relief gel products due to Current Good Manufacturing Practice (CGMP) deviations. The products were held outside of the appropriate storage temperature conditions.
The affected products include ORAJEL Gum Pain Relief Gel (SKU 903432), Good Sense Oral Pain Relief Gel (SKU 999543), ORAJEL Oral Pain Gel (SKU 912968), and ORAJEL Mouth Sore Gel (SKU 999075). These products were distributed to select Family Dollar store locations from April 30, 2022 through June 10, 2022.
The recall affects consumers who purchased these products during the distribution period from April 30, 2022 through June 10, 2022.
The recalled product
- Product
- ORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432 GOOD SENSE ORAL PAIN RELIEF 0.5OZ SKU 999543 ORAJEL ORAL PAIN 0.125 FL OZ SKU 912968 ORAJEL MOUTH SORE GEL 0.125 OZ SKU 999075 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug — Topical Pain Relief
- Hazard
- improper-storage
- product-degradation
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 (4)
- SKUs: 903432
- 999543
- 912968
- 999075
Distribution
Distributed nationwide across the United States.
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