Class II · Moderate risk
Sennazon (sennosides)
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
FDA Drug Recalls
917 recalls, newest first
Class I · High risk
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I
Non-Sterility; microbial contamination identified as Bacillus circulans
Class I · High risk
Comfort Shield
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Class I · High risk
Docusate Oral 10 mg/mL Oral Syringe
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Class I · High risk
Diocto Liquid
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Class II · Moderate risk
Sulfacetamide Sodium Ophthalmic Solution
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Class II · Moderate risk
Better Braids Un-Braid
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
Class II · Moderate risk
Medicated Better Braids
Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result.
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
tubby todd Bath Co
Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Class II · Moderate risk
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Class II · Moderate risk
Well at Walgreens Regular Strength Antacid Liquid
Products failed the Antimicrobial Effectiveness Test.
Class II · Moderate risk
Well at Walgreens Regular Strength Comfort Gel Cherry Flavor
Products failed the Antimicrobial Effectiveness Test
Class II · Moderate risk
Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ
Products failed the Antimicrobial Effectiveness Test
Class II · Moderate risk
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit)
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Class II · Moderate risk
Antacid Liquid Regular Strength Antacid & Anti-Gas
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.