US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

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

Donepezil HCL Tablets

Reason Subpotent

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-329-90 D-0784-2021
Class II · Moderate risk Terminated

Oxycodone Hydrochloride Tablets

Reason Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle

Rhodes Pharmaceuticals, L.P. NDC 42858-002-01 D-0794-2021
Class II · Moderate risk Terminated

Trulicity

Reason Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.

Eli Lilly & Company NDC 0002-1433-80 D-0773-2021
Class I · High risk Completed

X Rated Honey for Men

Reason Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

Phe Inc D-0819-2021
Class II · Moderate risk Terminated

Carvedilol 25 mg

Reason A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.

RemedyRepack Inc. NDC 68382-0095-05 D-0754-2021
Class II · Moderate risk Ongoing

Chantix

Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Pfizer Inc. NDC 0069-0469-03 D-0811-2021
Class II · Moderate risk Ongoing

Chantix

Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Pfizer Inc. NDC 0069-0469-56 D-0810-2021
Class II · Moderate risk Ongoing

Chantix

Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Pfizer Inc. NDC 0069-0468-56 D-0809-2021
Class II · Moderate risk Ongoing

Chantix

Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Pfizer Inc. NDC 00069-0471-03 D-0808-2021
Class II · Moderate risk Terminated

Betamethasone Dipropionate Lotion USP

Reason Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.

Akorn, Inc. NDC 61748-480-30 D-0802-2021
Class II · Moderate risk Terminated

Sodium Phenylbutyrate POWDER

Reason Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.

SigmaPharm Laboratories LLC NDC 42794-086-14 D-0766-2021
Class II · Moderate risk Terminated

Carvedilol Tablets

Reason Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle

Zydus Pharmaceuticals (USA) Inc NDC 68382-095-05 D-0753-2021
Class II · Moderate risk Terminated

Sodium Selinite 200mcg/Ml for Inj

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0067-2022
Class II · Moderate risk Terminated

Progesterone 100mg/Ml Mdv Oil Injection

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0066-2022
Class II · Moderate risk Terminated

Mit/B12 25/50/50mg/Ml 1mg/Ml Mdv

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0065-2022
Class II · Moderate risk Terminated

Mic/B12a/B6 15/50/100 5mg/50mg/Ml Mdv

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0064-2022
Class II · Moderate risk Terminated

Mic/B12a 25/50/50mg/Ml 1mg/Ml Mdv

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0063-2022
Class II · Moderate risk Terminated

Mic 25/50/50mg/Ml Mdv

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0062-2022
Class II · Moderate risk Terminated

Methylcobalamin 5000mcg/Ml Mdv Inj

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0061-2022
Class II · Moderate risk Terminated

Methylcobalamin 12.5mg/Ml Mdv Inj Soln

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0060-2022
Class II · Moderate risk Terminated

Methylcobalamin 1000mcg/Ml Mdv Inj

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0059-2022
Class II · Moderate risk Terminated

Methylcobalamin 10

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0058-2022
Class II · Moderate risk Terminated

Folic Acid 10mg/Ml Mdv Inj

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0057-2022
Class II · Moderate risk Terminated

Calcium Gluconate 10% Inj

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0056-2022