US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Class II · Moderate risk Terminated

Lorazepam Injection

Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Hikma Pharmaceuticals USA Inc. NDC 0641-6045-25 D-1310-2022
Class II · Moderate risk Terminated

Lorazepam Injection

Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Hikma Pharmaceuticals USA Inc. NDC 0641-6048-25 D-1309-2022
Class II · Moderate risk Terminated

Ativan Injection

Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Hikma Pharmaceuticals USA Inc. NDC 0641-6001-25 D-1308-2022
Class II · Moderate risk Terminated

Lorazepam Injection

Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Hikma Pharmaceuticals USA Inc. NDC 0641-6044-25 D-1307-2022
Class II · Moderate risk Terminated

Naftifine Hydrochloride Gel

Reason Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time

Tolmar, Inc. NDC 0115-1510-48 D-1300-2022
Class II · Moderate risk Terminated

Aripiprazole Tablets

Reason Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.

Apotex Corp. NDC 60505-2676-8 D-1285-2022
Class I · High risk Terminated

Insulin Glargine

Reason Labeling: Missing label: Label missing from some prefilled pens.

Mylan Pharmaceuticals Inc NDC 49502-394-71 D-1292-2022
Class II · Moderate risk Terminated

Succinylcholine Chloride Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1281-2022
Class II · Moderate risk Terminated

8.4% Sodium Bicarbonate Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1279-2022
Class II · Moderate risk Terminated

Ropivacaine HCl 123 mg

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1278-2022
Class II · Moderate risk Terminated

Rocuronium Bromide Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1277-2022
Class II · Moderate risk Terminated

Phenylephrine HCl Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1276-2022
Class II · Moderate risk Terminated

Phenylephrine HCl Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1275-2022
Class II · Moderate risk Terminated

Phenylephrine HCl Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1274-2022
Class II · Moderate risk Terminated

Oxytocin 30 Units/500 mL

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1273-2022
Class II · Moderate risk Terminated

Neostigmine Methylsulfate Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1272-2022
Class II · Moderate risk Terminated

Neostigmine Methylsulfate Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1271-2022
Class II · Moderate risk Terminated

Neostigmine Methylsulfate Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1270-2022
Class II · Moderate risk Terminated

Morphine Sulfate Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1268-2022
Class II · Moderate risk Terminated

Morphine Sulfate Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1267-2022
Class II · Moderate risk Terminated

Morphine Sulfate Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1266-2022
Class II · Moderate risk Terminated

Morphine Sulfate Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1265-2022
Class II · Moderate risk Terminated

Lidocaine HCl Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1264-2022