US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class I · High risk Terminated

The Red Pill

Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Your Favorite Shop D-0630-2022
Class I · High risk Terminated

MAC DADDY PURPLE Capsules

Reason Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.

ABC Sales 1 Inc D-0563-2022
Class I · High risk Terminated

MAC DADDY RED Capsules

Reason Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.

ABC Sales 1 Inc D-0562-2022
Class II · Moderate risk Terminated

Erythromycin Topical Gel USP

Reason Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.

Teligent Pharma, Inc. NDC 63739-053-66 D-0716-2022
Class II · Moderate risk Terminated

Chlorthalidone Tablets USP 25 mg

Reason Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup

Sun Pharmaceutical Industries INC NDC 57664-648-88 D-0578-2022
Class I · High risk Terminated

Paragard T380a

Reason Non-sterility

CooperSurgical, Inc NDC 51285-204-01 D-0643-2022
Class II · Moderate risk Terminated

Prevantics

Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

Professional Disposables International, Inc. NDC 10819-4077-1 D-0572-2022
Class II · Moderate risk Terminated

Prevantics

Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

Professional Disposables International, Inc. NDC 10819-1080-1 D-0571-2022
Class II · Moderate risk Terminated

Prevantics

Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

Professional Disposables International, Inc. NDC 10819-4076-4 D-0570-2022
Class I · High risk Terminated

MegMan Performance Booster

Reason Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Junp Hydration LLC D-0557-2022
Class I · High risk Terminated

Morphine Sulfate PF 25 mg/25mL

Reason Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A

STAQ Pharma, Inc. D-0634-2022
Class I · High risk Terminated

HYDROmorphone HCl PF 10 mg/50 mL

Reason Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A

STAQ Pharma, Inc. D-0633-2022
Class I · High risk Terminated

Hard Dawn

Reason Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.

Esupplementsales, LLC D-0561-2022
Class I · High risk Terminated

Polymyxin B for Injection USP

Reason Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot

AuroMedics Pharma LLC NDC 55150-234-10 D-0556-2022
Class II · Moderate risk Terminated

Cystex Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. D-0555-2022
Class II · Moderate risk Terminated

DBI Magnums Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-941-00 D-0554-2022
Class II · Moderate risk Terminated

Coated Back Relief Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-800-00 D-0553-2022
Class II · Moderate risk Terminated

Legatrin

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-785-00 D-0552-2022
Class II · Moderate risk Terminated

Back Relief II

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-740-00 D-0551-2022
Class II · Moderate risk Terminated

Pain Aid PMF Caplet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-710-00 D-0550-2022
Class II · Moderate risk Terminated

Normed Fem Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-701-00 D-0549-2022
Class II · Moderate risk Terminated

APAP 325 mg

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-700-00 D-0548-2022
Class II · Moderate risk Terminated

Migrenol Caplet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-565-00 D-0547-2022
Class II · Moderate risk Terminated

Phenylephrine HCl 5 mg Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-333-00 D-0545-2022