Class I · High risk
fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection
Subpotent Drug
FDA Drug Recalls
1,711 recalls, newest first
Class I · High risk
Atropine Sulfate Injection Solution
Subpotent Drug
Class I · High risk
fentaNYL citrate in 0.9% Sodium Chloride Injection
Subpotent Drug
Class II · Moderate risk
Class II · Moderate risk
Class III · Low risk
Hydrocortisone and Acetic Acid Otic Solution
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
Class II · Moderate risk
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Class II · Moderate risk
Ketamine Hydrochloride Injection
Defective Container: There were customer complaints of cracked and leaking glass vials.
Class III · Low risk
Rifampin for Injection USP
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Class II · Moderate risk
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Lidocaine HCI
Stability data does not support expiry.
Class II · Moderate risk
Midazolam 1 mg/mL in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Ketamine 50 mg/mL
Stability data does not support expiry.
Class II · Moderate risk
Morphine Sulfate
Stability data does not support expiry.
Class II · Moderate risk
Ketamine 100 mg/mL
Stability data does not support expiry.
Class II · Moderate risk
Glycopyrrolate 0.2 mg/mL
Stability data does not support expiry.
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Morphine Sulfate
Stability data does not support expiry.
Class II · Moderate risk
Fentanyl Citrate
Stability data does not support expiry.
Class II · Moderate risk
Midazolam
Stability data does not support expiry.
Class II · Moderate risk
Ondansetron 2 mg/mL
Stability data does not support expiry.