US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated

Phenylephrine HCl Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC NDC 69374-301-10 D-0361-2023
Class II · Moderate risk Terminated

Phenylephrine HCl Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC NDC 69374-305-10 D-0360-2023
Class II · Moderate risk Terminated

Phenylephrine HCl Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC NDC 69374-302-10 D-0359-2023
Class II · Moderate risk Terminated

Phenylephrine HCl 20 mg

Reason CGMP DEVIATIONS

Denver Solutions, LLC DBA Leiters Health NDC 71449-148-94 D-0445-2023
Class II · Moderate risk Terminated

Phenylephrine HCl 40 mg

Reason CGMP DEVIATIONS

Denver Solutions, LLC DBA Leiters Health NDC 71449-150-82 D-0444-2023
Class II · Moderate risk Terminated

Phenylephrine HCl 1mg per 10mL

Reason CGMP DEVIATIONS

Denver Solutions, LLC DBA Leiters Health NDC 71449-001-15 D-0443-2023
Class II · Moderate risk Terminated

Phenylephrine HCl 0.5 mg per 5 mL

Reason CGMP DEVIATIONS

Denver Solutions, LLC DBA Leiters Health NDC 71449-001-11 D-0442-2023
Class II · Moderate risk Terminated

Testosterone Cypionate Injection

Reason cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Azurity Pharmaceuticals, Inc. NDC 52536-625-10 D-0489-2023
Class II · Moderate risk Terminated

Warfarin Sodium Tablets

Reason Failed Impurities/Degradation Specifications

Rising Pharmaceuticals NDC 57237-119-01 D-0348-2023
Class II · Moderate risk Terminated

Allergy Relief

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 36800-691-39 D-0912-2023
Class II · Moderate risk Terminated

Picnic

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company D-0911-2023
Class II · Moderate risk Terminated

allergy relief

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 11673-617-22 D-0910-2023
Class II · Moderate risk Terminated

allergyrelief

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 56062-847-39 D-0909-2023
Class II · Moderate risk Terminated

Fexofenadine Hydrochloride Tablets

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 0113-0847-39 D-0908-2023
Class II · Moderate risk Terminated

Fexofenadine Hydrochloride Tablets

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 45802-847-78 D-0907-2023
Class II · Moderate risk Terminated

allergy relief

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 79481-0847-0 D-0906-2023
Class II · Moderate risk Terminated

Allergy ALLER-FEX

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 63981-847-48 D-0905-2023
Class II · Moderate risk Terminated

aller-ease

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 55301-847-39 D-0904-2023
Class II · Moderate risk Terminated

Allergy Relief

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 69842-0914-39 D-0903-2023
Class II · Moderate risk Terminated

Allergy Relief

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 72476-847-22 D-0902-2023