FDA Drug Recalls

18 recalls · Class II, newest first

Dec 22, 2015 Class II · Moderate risk

Energique

Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Terminated Microbial contamination Grato Holdings, Inc. NDC 44911-0135-1 D-0580-2016

Dec 22, 2015 Class II · Moderate risk

Energique

Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Terminated Microbial contamination Grato Holdings, Inc. NDC 44911-0134-1 D-0579-2016

Dec 22, 2015 Class II · Moderate risk

Energique

Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Terminated Microbial contamination Grato Holdings, Inc. NDC 44911-0137-1 D-0578-2016

Dec 22, 2015 Class II · Moderate risk

Energique

Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Terminated Microbial contamination Grato Holdings, Inc. NDC 44911-0133-1 D-0577-2016

Dec 22, 2015 Class II · Moderate risk

Energique

Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Terminated Microbial contamination Grato Holdings, Inc. NDC 44911-0132-1 D-0576-2016

Dec 22, 2015 Class II · Moderate risk

Energique

Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Terminated Microbial contamination Grato Holdings, Inc. NDC 44911-0136-1 D-0575-2016

Nov 12, 2015 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.

Terminated Microbial contamination Mariposa Labs LLC D-0510-2019

Nov 11, 2015 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.

Terminated Microbial contamination Fagron, Inc NDC 51552-1079-9 D-0656-2016

Nov 11, 2015 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.

Terminated Microbial contamination Fagron, Inc NDC 51552-1167-9 D-0655-2016

Nov 11, 2015 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.

Terminated Microbial contamination Fagron, Inc NDC 51552-1079-5 D-0654-2016

Apr 30, 2015 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.

Terminated Microbial contamination Mission Pharmacal Co NDC 44523-616-23 D-1065-2015

Apr 30, 2015 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.

Terminated Microbial contamination Mission Pharmacal Co NDC 44523-0609-23 D-1064-2015

Apr 16, 2015 Class II · Moderate risk

Well at Walgreens Regular Strength Antacid Liquid

Products failed the Antimicrobial Effectiveness Test.

Terminated Microbial contamination Tarmac Products, Inc. D-968-2015

Apr 16, 2015 Class II · Moderate risk

Well at Walgreens Regular Strength Comfort Gel Cherry Flavor

Products failed the Antimicrobial Effectiveness Test

Terminated Microbial contamination Tarmac Products, Inc. D-967-2015

Apr 16, 2015 Class II · Moderate risk

Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ

Products failed the Antimicrobial Effectiveness Test

Terminated Microbial contamination Tarmac Products, Inc. D-966-2015

Mar 6, 2015 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.

Terminated Microbial contamination Fusion Pharmaceuticals, LLC D-0410-2015

Feb 6, 2015 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.

Terminated Microbial contamination Tarmac Products, Inc. NDC 0363-0073-02 D-0419-2015

Jan 28, 2015 Class II · Moderate risk

Erythromycin Pledgets USP

Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.

Terminated Microbial contamination Akorn, Inc. NDC 61748-202-60 D-0385-2015

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061