FDA Drug recall D-061-2013
Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 085…
- FDA Drug
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 085… by Church And Dwight, citing CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-061-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-06 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Church And Dwight |
| Distribution | US |
Product
Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7.
Reason
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Identifiers
| upc | 310310323707 |
|---|---|
| code_info | Lot #: BI1041, Exp 02/13 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Church And Dwight
- Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distri…
FDA Drug · Class II · 2026-09-02 · Church And Dwight - ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc
FDA Drug · Class II · 2025-10-29 · Church And Dwight - Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Ma…
FDA Drug · Class I · 2025-07-09 · Church And Dwight - ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30…
FDA Drug · Class I · 2025-07-09 · Church And Dwight - ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
FDA Drug · Class I · 2025-07-09 · Church And Dwight
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-061-2013%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.