FDA Drug recall D-1381-2022
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 M…
- FDA Drug
- Class II
- ongoing
- Published 2022-08-31
On 2022-08-31 the FDA classified a Class II recall of 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 M… by Family Dollar Stores, citing CGMP Deviations: product held outside appropriate storage temperature conditions.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1381-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-23 |
| Published | 2022-08-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Family Dollar Stores |
| Distribution | US |
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.
Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Identifiers
| code_info | SKUs: 903432; 999543; 912968; 999075 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1381-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.