US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Class II · Moderate risk Terminated

Labetalol 20mg

Reason Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.

Avella of Deer Valley, Inc. Store 38 NDC 42852-822-71 D-0997-2019
Class III · Low risk Terminated

Mometasone Furoate Cream

Reason Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.

ACP Nimble Buyer, Inc. NDC 0713-0726-37 D-0514-2019
Class II · Moderate risk Terminated

Express Gel Hand Sanitizer

Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Ecolab Inc NDC 47593-502-49 D-1064-2019
Class II · Moderate risk Terminated

Quick-Care Foam Hand Sanitizer

Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Ecolab Inc NDC 47593-491-85 D-1063-2019
Class II · Moderate risk Terminated

Moisturizing Gel Hand Sanitizer

Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Ecolab Inc NDC 47593-489-33 D-1062-2019
Class II · Moderate risk Terminated

Advanced Gel Hand Sanitizer

Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Ecolab Inc NDC 47593-488-49 D-1061-2019
Class II · Moderate risk Terminated

Gel Hand Sanitizer

Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Ecolab Inc NDC 47593-487-49 D-1060-2019
Class III · Low risk Terminated

Oxytocin 30 Units added to NS 500 mL

Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

Advanced Pharma Inc. NDC 42852-706-50 D-0499-2019
Class III · Low risk Terminated

Oxytocin 20 Units added to NS 1000 mL

Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

Advanced Pharma Inc. NDC 42852-703-99 D-0498-2019
Class III · Low risk Terminated

Oxytocin 10 Units added to NS 1000 mL

Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

Advanced Pharma Inc. NDC 42852-730-99 D-0497-2019
Class II · Moderate risk Terminated

Moisturizing Lubricant Eye Drops

Reason Failed Stability Specification: out of specification results for Sodium Perborate

Akorn Inc NDC 00363-9651-01 D-0511-2019
Class I · High risk Terminated

Levoleucovorin Injection

Reason Presence of Particulate Matter: particulate matter identified as copper salts

Mylan Institutional Inc D-1059-2019
Class III · Low risk Terminated

Moxifloxacin Ophthalmic Solution USP

Reason Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.

Lupin Pharmaceuticals Inc. NDC 68180-422-01 D-0484-2019
Class II · Moderate risk Terminated

Dymista

Reason Defective Container: Potential for broken glass in the neck area of the glass bottles.

Mylan Pharmaceuticals Inc. NDC 0037-0245-23 D-0424-2019
Class II · Moderate risk Terminated

Divalproex Sodium Extended-release Tablets

Reason Failed Dissolution Specifications: Out of specification results observed for high dissolution.

Dr. Reddy's Laboratories, Inc. NDC 55111-533-01 D-0507-2019
Class III · Low risk Terminated

Diltiazem HCl CD capsules

Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

Valeant Pharmaceuticals North America LLC NDC 68682-521-01 D-0491-2019
Class III · Low risk Terminated

Cardizem CD

Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

Valeant Pharmaceuticals North America LLC NDC 0187-0798-30 D-0490-2019
Class III · Low risk Terminated

Cardizem CD

Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

Valeant Pharmaceuticals North America LLC NDC 0187-0797-30 D-0489-2019
Class III · Low risk Terminated

Cardizem CD

Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

Valeant Pharmaceuticals North America LLC NDC 0187-0796-30 D-0488-2019
Class III · Low risk Terminated

Cardizem CD

Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

Valeant Pharmaceuticals North America LLC NDC 0187-0795-30 D-0487-2019
Class II · Moderate risk Terminated

Ephedrine Sulfate

Reason Lack of assurance of sterility.

US Compounding Inc D-0508-2019
Class III · Low risk Terminated

Bimatoprost Ophthalmic Solution 0.03%

Reason Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.

Lupin Pharmaceuticals Inc. NDC 68180-429-02 D-0429-2019