Independent register of U.S. FDA drug recalls · updated Oct 14, 2026
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FDA Drug Recalls

11,818 recalls · Class II, newest first

Class II · Moderate risk

hydrALAZINE HYDROCHLORIDE INJECTION

Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.

Terminated Temperature excursion Mckesson Medical Surgical NDC 63323-614-01 D-0668-2017
Class II · Moderate risk

ATENOLOL Tablets

Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.

Terminated Particulate / foreign matter Legacy Pharmaceutical Packaging LLC NDC 68645-493-54 D-0606-2017
Class II · Moderate risk

Tiger King tablets

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0572-2018
Class II · Moderate risk

MAX MAN capsules

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0565-2018
Class II · Moderate risk

STREE OVERLORD capsules

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0564-2018
Class II · Moderate risk

Ye Lang Shen capsules

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0561-2018
Class II · Moderate risk

HARD TEN DAYS capsules

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0557-2018
Class II · Moderate risk

Black Ant capsules

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0552-2018
Class II · Moderate risk

ATENOLOL Tablets

Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.

Terminated Particulate / foreign matter Zydus Pharmaceuticals USA Inc NDC 68382-023-01 D-0605-2017
Class II · Moderate risk

Desonide Ointment

Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream

Terminated Labeling / mix-up Fougera Pharmaceuticals Inc. NDC 0168-0309-60 D-0612-2017
Class II · Moderate risk

Sodium Citrate all strengths

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Terminated Labeling / mix-up Advanced Pharma Inc. D-0851-2017
Class II · Moderate risk

Bumetadine all strengths

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Terminated Labeling / mix-up Advanced Pharma Inc. D-0844-2017
Class II · Moderate risk

Famotidine HCl all strengths

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Terminated Labeling / mix-up Advanced Pharma Inc. D-0842-2017

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