US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Jun 23, 2022 (4 years ago)

Orajel Gum Pain Relief Gel 0.125oz Sku 903432 Good Sense Oral Pain Relief 0.5oz Sku…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: product held outside appropriate storage temperature conditions.

What was recalled

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.

Recalling firm
Family Dollar Stores, Llc.
Origin
VA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1381-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.