US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Class I · High risk Terminated

GOLD VIGRA capsules

Reason 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.

A&H Focal Inc. D-0559-2018
Class I · High risk Terminated

LANG YI HAO CHAONONGSUOPIAN tablets

Reason 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.

A&H Focal Inc. D-0558-2018
Class II · Moderate risk Terminated

HARD TEN DAYS capsules

Reason 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.

A&H Focal Inc. D-0557-2018
Class I · High risk Terminated

GERMANY NIUBIAN tablets

Reason 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.

A&H Focal Inc. D-0556-2018
Class I · High risk Terminated

GERMANY BLACK GOLD tablets

Reason 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.

A&H Focal Inc. D-0555-2018
Class I · High risk Terminated

Miraculous Evil Root capsules

Reason 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.

A&H Focal Inc. D-0554-2018
Class III · Low risk Terminated

Indian God Lotion Spray Bottle

Reason Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.

A&H Focal Inc. D-0553-2018
Class II · Moderate risk Terminated

Black Ant capsules

Reason 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.

A&H Focal Inc. D-0552-2018
Class III · Low risk Terminated

RIVASTIGMINE Tartrate Capsules

Reason Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.

Dr. Reddy's Laboratories, Inc. NDC 55111-352-60 D-0649-2017
Class II · Moderate risk Terminated

Sensodyne Repair & Protect Whitening

Reason Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent

GSK Consumer Healthcare NDC 0135-0575-01 D-0624-2017
Class II · Moderate risk Terminated

ATENOLOL Tablets

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

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

Desonide Ointment

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

Fougera Pharmaceuticals Inc. NDC 0168-0309-60 D-0612-2017
Class III · Low risk Terminated

Clindamycin Phosphate Topical Solution USP

Reason CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.

G & W Laboratories, Inc. NDC 0472-0987-91 D-0519-2017
Class III · Low risk Terminated

Penicillin V Potassium Tablets

Reason Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg

Citron Pharma Llc NDC 57237-041-99 D-0652-2017
Class II · Moderate risk Terminated

Sodium Citrate all strengths

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

Advanced Pharma Inc. D-0851-2017
Class II · Moderate risk Terminated

Sodium Phosphate all strengths

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

Advanced Pharma Inc. D-0850-2017
Class II · Moderate risk Terminated

Potassium Phosphate all strengths

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

Advanced Pharma Inc. D-0849-2017
Class II · Moderate risk Terminated

Magnesium Sulfate all strengths

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

Advanced Pharma Inc. D-0848-2017
Class II · Moderate risk Terminated

Dexmedetomidine HCl all strengths

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

Advanced Pharma Inc. D-0846-2017
Class II · Moderate risk Terminated

Dexamethasone Sodium Phosphate all strengths

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

Advanced Pharma Inc. D-0845-2017
Class II · Moderate risk Terminated

Bumetadine all strengths

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

Advanced Pharma Inc. D-0844-2017
Class II · Moderate risk Terminated

Ondansetron HCl all strengths

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

Advanced Pharma Inc. D-0843-2017