CLASS II Drug recall · Reported 24 Jul 2013 · FDA Enforcement Report
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer recalled
Church & Dwight is recalling Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, distributed nationwide in the US. The recall was initiated on 11 Jun 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-801-2013
- FDA event ID
- 65642
- Recalling firm
- Church & Dwight, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jun 2013
- FDA classified
- 12 Jul 2013
- Reported
- 24 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
Timeline
| 11 Jun 2013 | Recall initiated by company | |
| 12 Jul 2013 | Classified by FDA | +31 days |
| 24 Jul 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 5 Coarse Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60511.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Which lots are affected?
Lot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 65642This product is part of a recall event; the main page for the event is Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer recalled | Church & Dwight | Foreign Material | Nationwide | |
| CLASS II | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer recalled | Church & Dwight | Foreign Material | Nationwide | |
| CLASS II | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer recalled | Church & Dwight | Foreign Material | Nationwide | |
| CLASS II | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer recalled | Church & Dwight | Foreign Material | Nationwide |
More recalls from Church & Dwight
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zicam, Cold Remedy, Medicated Nasal Swabs recalled by Church & Dwight Co | Church & Dwight | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zicam" Medicated Fruit Drops Elderberry Flavor, 25-drops recalledZicam Cold Remedy Medicated Fruit Drops - Elderberry | Church & Dwight | Packaging Defects | Nationwide |
| Drug | CLASS I | Zicam Nasal All recalled by Church & Dwight | Church & Dwight | Sterility | Nationwide |
| Drug | CLASS I | Zicam Cold Remedy Medicated Nasal Swabs-Use Swabs recalled | Church & Dwight | Sterility | Nationwide |
| Drug | CLASS I | Orajel Baby, Cooling Swabs for Teething, Each Unit recalled | Church & Dwight | Sterility | Nationwide |
Other Sodium Bicarbonate recalls
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/ (0.5 mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Lead & Heavy Metals | Nationwide |
| Drug | CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Sterility | Nationwide |
| Drug | CLASS I | 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS I | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/ (0.5 mEq/mL) recalled | Pfizer | Particulate Matter | Nationwide |