Food, drugs, devices › Church & Dwight Inc

Device recall: Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialys

FDA enforcement event 65686 · Class II · initiated 11 Jun 2013 · status Terminated · terminated 30 Jun 2015

DeviceVoluntary: Firm initiated1 product recordPrinceton, NJ

Church & Dwight Inc (Princeton, NJ) initiated this device recall on 11 Jun 2013; FDA lists 1 product record under event 65686, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 30 Jun 2015. 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

"Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination."

Distribution

"Nationwide Distribution including IL, PA, IN, OH, MI, TN, TX, MN, MO, NJ, KY,and MD."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1811-2013	Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs	234 sacks at 2500 lbs. each of Dialysis Grade 1.5 ; 880 bags at 50 lbs. each of Dialysis Grade 2	Class II	Terminated	31 Jul 2013

Context

90%of 2013 device events are Class II1,236 events that year

1product record 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
6 Jun 2025	ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing	Drug	Class I	3
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 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 device recalled?

FDA's record gives the reason for recall as: "Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide Distribution including IL, PA, IN, OH, MI, TN, TX, MN, MO, NJ, KY,and MD."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 30 Jun 2015. "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 device 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.