Class II · Moderate risk
Orajel Gum Pain Relief Gel 0.125oz Sku 903432 Good Sense Oral…
CGMP Deviations: product held outside appropriate storage temperature conditions.
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class II · Moderate risk
Orajel Cold Sore Pain Cream 1.25 fl. oz. distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Doctor Dandruf 2n1 Shamp Cln Apl 13.5floz Sku 2005726 Suave 2n1…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Disney Licensed Anti Bac Wipes 20 Ct Sku 998908
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
DIAL MENS EUCALYPTUS AB BODY WASH 20 FLOZ SKU 2096030 distributed…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Aleve Analgesic Back Muscle 24 Ct Sku 999787 Aleve Pm Caplets…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Dr Scholls Anti Fungal Spray Pwder 4.7 Oz Sku 998250 Premier…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
FS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Motrin Ib Caplets 24ct Sku999394
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Softsoap Anti Bactrial Lq Soap 11.25 Floz Sku 2005090 Dial Lhs…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Suave Inv Sld Pwdr 1.2 Oz Sku2004504 Suave Ap Inv Solid Sweet…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Hydrogen Peroxide 16 fl. oz. and 32 oz. bottles distributed to…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Colgate Max Fresh Clean Mint 1.9oz Sku 900596 Colgate Cavity…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Dermasil Dry Skin Treatment 10 OZ SKU 2098068 Aveeno Daily…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Banana Boat Sprt Clr Spry Spf50 6 Fl Oz Sku 2007524 Suntone…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Novelty Hand Sanitizer with Silicone Wrap SKU 998890 Novelty…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP - Water leakage
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class I · High risk
Morphine Sulfate extended-Release Tablets
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class I · High risk
Morphine Sulfate extended-Release Tablets
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class II · Moderate risk
Draximage MAA
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.