Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

4 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2011 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Prefera OB One Gel Capsules

Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP.

Terminated Labeling / mix-up Meda Pharmaceuticals Inc. NDC 68220-086-30 D-1418-2012
Class II · Moderate risk

Docusate Calcium Softgel Capsules

Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 00904-5779-60 D-1451-2014
Class II · Moderate risk

Sulfamethoxazole and Trimethoprim Tablets

Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 53746-272-01 D-1450-2014
Class II · Moderate risk

Pramipexole Dihydrochloride Tablets

Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 16714-586-01 D-1449-2014

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