Class II · Moderate risk
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml…
Lack of sterility assurance.
FDA Drug Recalls
1,590 recalls, newest first
Class II · Moderate risk
Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL…
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes…
Lack of sterility assurance.
Class II · Moderate risk
Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV…
Lack of sterility assurance.
Class II · Moderate risk
Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes…
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump…
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump…
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump…
Lack of sterility assurance.
Class II · Moderate risk
Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL…
Lack of sterility assurance.
Class II · Moderate risk
Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes…
Lack of sterility assurance.
Class II · Moderate risk
Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL…
Lack of sterility assurance.
Class II · Moderate risk
Magnesium Sulfate 200 mg/mL
Lack of sterility assurance.
Class II · Moderate risk
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL…
Lack of sterility assurance.
Class II · Moderate risk
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials…
Lack of sterility assurance.
Class II · Moderate risk
Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes…
Lack of sterility assurance.
Class II · Moderate risk
Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV…
Lack of sterility assurance.
Class II · Moderate risk
EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled…
Lack of sterility assurance.
Class II · Moderate risk
B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial…
Lack of sterility assurance.
Class II · Moderate risk
Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml…
Lack of sterility assurance.
Class II · Moderate risk
Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100…
Lack of sterility assurance.
Class II · Moderate risk
Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD…
Lack of sterility assurance.
Class I · High risk
7K capsules packaged in single packs sold in 24-count boxes
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
POSEIDON Xtreme PLATINUM 4500
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class II · Moderate risk
My Way (levonorgestrel)
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Class II · Moderate risk
My Way (Levonorgestrel)
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.