Class II · Moderate risk
BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion
Lack of sterility assurance.
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class II · Moderate risk
BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj…
Lack of sterility assurance.
Class II · Moderate risk
Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
Alprostadil 40 mcg/mL
Lack of sterility assurance.
Class III · Low risk
PCA Skin Blemish Control Bar
Superpotent Drug: Salicylic acid content is above the firm's specification.
Class II · Moderate risk
Testosterone Topical Cream 4%
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Tadalafil 6 mg Capsule
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Tadalafil 20 mg Troche
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
T3/T4 SR 9 mcg/38 mcg capsule
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Squaric Acid 0.1% Topical Solution
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Sildenafil 80 mg capsules
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Sildenafil 200 mg Troche
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Progesterone E4M SR 100 mg capsules
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Progesterone 50 mg capsules
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Progesterone 200 mg Troche
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Naltrexone 4.5 mg capsule
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Magic Bullet Supplement
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Liothyronine
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Liothyronine
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Finasteride/Biotin 1 mg/50 mcg
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
DHEA/Pregnenol One 10.25 MG Cap
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class I · High risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)