Browse Drug Recalls
10 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 10 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 10 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 6, 2025 | ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church ... | Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. | Class I | Church & Dwight Inc |
| Jun 6, 2025 | ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Dist... | Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. | Class I | Church & Dwight Inc |
| Jun 6, 2025 | Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET... | Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs. | Class I | Church & Dwight Inc |
| Sep 8, 2023 | TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride i... | Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis | Class I | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Sep 6, 2012 | Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, ... | CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substitu... | Class II | Church & Dwight Inc |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.