Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

FDA Drug Recalls

8 recalls, 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
Class I · High risk

metFORMIN ER Tablets

Labeling: Label Mix up; product labeled did not indicated Extended Release

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 53746-178-01 D-1448-2014
Class I · High risk

Oxycodone HCl Oral Concentrate

Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 00527-1426-36 D-1447-2014
Class I · High risk

Taztia XT (Diltiazem HCl)

Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 62037-0696-90 D-1446-2014
Class III · Low risk

Metoclopramide Oral Solution

Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"

Terminated Labeling / mix-up VistaPharm, Inc. D-1669-2012

Recalls by year