Food, drugs, devices › Church & Dwight Inc

Drug recall: ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing

FDA enforcement event 97031 · Class I · initiated 6 Jun 2025 · status Ongoing

DrugVoluntary: Firm initiated3 product recordsPrinceton, NJ

FDA enforcement event 97031 is a drug recall by Church & Dwight Inc of Princeton, NJ, initiated 6 Jun 2025 and classified Class I, with 3 product records.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 9% of the 322 drug enforcement events initiated in 2025 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Church & Dwight Inc has 9 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Church & Dwight Inc, Princeton, NJ.

Reason for recall

"Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs."

Distribution

"Nationwide in the USA."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0504-2025	ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5	3,374,918 cartons	Class I	Ongoing	9 Jul 2025
D-0505-2025	ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6	13,632 cartons	Class I	Ongoing	9 Jul 2025
D-0506-2025	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, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.	695,880 cartons	Class I	Ongoing	9 Jul 2025

Context

9%of 2025 drug events are Class I322 events that year

3product records in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for Church & Dwight Inc

Initiated	Product (first record)	Type	Class	Records
8 Sep 2023	TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry	Drug	Class I	1
25 Jan 2023	Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test re	Device	Class II	1
4 Jun 2015	Gummy Vites Complete Multivitamin L'il Critters 70 gummies Manufactured for Church & Dwight Co., Inc. Ewing, NJ 08628	Food	Class II	1
12 Jun 2013	Arm & Hammer Baking Soda a) Net Wt. 1 LB. (454 g) UPC 3320001130 b) Net Wt. 8 oz. (277 g) UPC 3320001110 Church & Dwight	Food	Class II	1
11 Jun 2013	Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialys	Device	Class II	1
11 Jun 2013	Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities,	Drug	Class II	5
6 Sep 2012	Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc.	Drug	Class II	1
22 Dec 2011	Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made in China. Manufactured for Churc	Device	Class II	10

All 9 events for Church & Dwight Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide in the USA."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.