ORAJEL GUM PAIN RELIEF GEL 0 — Class II drug recall D-1381-2022
Ongoing recall by Family Dollar Stores, Llc., reported 2022-08-31, distributed nationwide. CGMP Deviations: product held outside appropriate storage temperature conditions.
| Recall number | D-1381-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Family Dollar Stores, Llc., Chesapeake, VA, United States |
| Recall initiated | 2022-06-23 |
| Classified | 2022-08-22 |
| Reported by FDA | 2022-08-31 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
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 for recall
CGMP Deviations: product held outside appropriate storage temperature conditions.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1381-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.