Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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FDA Drug Recalls

18,003 recalls, newest first

Class II · Moderate risk

Cetirizine Oral Solution 1 mg/mL

cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Terminated Microbial contamination P & L Developments, LLC NDC 11673-178-04 D-1409-2019
Class II · Moderate risk

Cetirizine Oral Solution 1 mg/mL

cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Terminated Microbial contamination P & L Developments, LLC NDC 63868-430-04 D-1408-2019
Class II · Moderate risk

Cetirizine HCL Oral Solution 1 mg/mL

cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Terminated Microbial contamination P & L Developments, LLC NDC 55910-878-04 D-1407-2019
Class II · Moderate risk

Allergy Relief D

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

Terminated Impurity / degradation Sun Pharmaceutical Industries, Inc. D-1388-2019
Class II · Moderate risk

Allergy Relief D

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

Terminated Impurity / degradation Sun Pharmaceutical Industries, Inc. D-1387-2019
Class II · Moderate risk

Estradiol Vaginal Inserts USP 10 mcg

Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.

Terminated Packaging defect Glenmark Pharmaceuticals Inc., USA NDC 68462-711-71 D-1340-2019
Class II · Moderate risk

ZYFLO CR (zileuton)

Failed Dissolution Specifications: Out of specification result for dissolution.

Terminated Dissolution failure Chiesi USA, Inc. NDC 10122-902-12 D-1341-2019
Class II · Moderate risk

Sn-d

Lack of Processing Controls.

Terminated cGMP deviation Synthetopes Inc D-1403-2019

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