Class II · Moderate risk
Pseudoephedrine Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection.
1,002 FDA drug recalls with this cause, newest first.
These recalls involve bacteria, mold, yeast or other microorganisms actually found in the finished product. This overlaps with sterility issues but is tracked separately because it usually points to a specific breakdown - a water system, an unsealed container, a contaminated raw material - rather than a general process failure. It carries a large share of Class I recalls: an organism such as Burkholderia cepacia or Pseudomonas in an eye drop, nasal spray or oral liquid can cause serious infection.
Class II · Moderate risk
Banophen Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Robafen DM Syrup
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Robafen AC Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Robafen Cough Formula Expectorant
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Children's Mapap Acetaminophen Liquid
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Allergy Liquid Antihistamine
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Children's Acetaminophen Liquid
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
RisperiDONE Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
CVS Health Children's Nasal Saline Drops With Himalayan Salt…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
DrKids Children's Natural Cough Syrup English Ivy Leaf Organic…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
DrKids Children's Cough & Chest Congestion DM
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
CVS Health Children's Allergy Relief Liquid Medication…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
CVS Health Children's Mucus Relief Chest Congestion Plus Cough…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class I · High risk
Maeng Da Kratom
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class I · High risk
White Vein Kratom
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class I · High risk
White Vein Kratom
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class I · High risk
Maeng Da Kratom
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class II · Moderate risk
Medline Remedy Essential Barrier Skin Protectant Ointment
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.