Browse Drug Recalls

1,152 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,152 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 1,152 FDA drug recalls in 2021.

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DateProductReasonClassFirm
Aug 20, 2021 ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturin... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Quebracho 4C, Fever*, 20% Alcohol, Packaged as 100ml, WHP Homeopathic Medicin... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Z-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Ma... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Strophanthus hisp 30X, Hives*, 20% Alcohol, Packaged in (a) 15 mL, UPC 7 4064... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Althaea 30X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, W... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Yeast Guard Blend, Calcarea Carbonica 6X, Collinsonia Canadensis 3X, Kali Mu... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Althaea Officinalis 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as ... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 6X, 26X, 30X, packaged in 15mL ... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Cedar Fever Drops, 20% USP ALCOHOL, 30 mL, homeopathic drug for symptoms of c... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: ... Subpotent Class III Jubilant Cadista Pharmaceuticals, Inc.
Aug 20, 2021 Viola Odorata 4X, 10X, 12X, Bee Stings*, Sucrose/Lactose Pills, 4X Packaged ... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 ZTE 1013 Formula Antimicrobial - F&M , Contents 1000 ml, REMEDY: Bryonia Alba... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Aconitum nap Fear* 87% Alcohol HPUS: 5X, 7X, 18X, 30X, packaged in 30 mL cont... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arseni... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Kali Sulphuricum 3X, 960ml 20% Alcohol, WHP Homeopathic Medicine, For Manufac... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Humulus 6X, 15X, Sucrose/Lactose Pills, 6X Packaged as a) 4dr, UPC 7 40640 33... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Verbena Officinalis 6X, Nervousness* Sucrose/Lactose Pills, Packaged 2 Dram, ... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medici... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 ZTE-105 Formula Gentle Detoxing. Contents 1000 mL, RX Only, REMEDY: Bryoni Al... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 5X, 6X,15X, packaged in 1 ... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Occular Allergy Blend 87% Alcohol; In Equal Parts of Apis Mellifica 7x Allium... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 19, 2021 Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Mark... Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/2... Class II Rhodes Pharmaceuticals, L.P.
Aug 19, 2021 Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only,... Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL act... Class II Eli Lilly & Company
Aug 18, 2021 X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 1368... Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. Class I Phe Inc
Aug 18, 2021 Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Green... Lack of Assurance of Sterility Class II Prescription Labs Inc dba Greenpark
Aug 17, 2021 Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pen... A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product w... Class II RemedyRepack Inc.
Aug 13, 2021 MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by:... Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle Class II Zydus Pharmaceuticals (USA) Inc
Aug 13, 2021 ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 m... Failed impurities/degradation specification: Out of Specification for an unknown impurity observe... Class II Akorn, Inc.
Aug 13, 2021 MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfiz... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 13, 2021 LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compoundin... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 13, 2021 MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mounta... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laborator... Failed Impurities Specifications: Out of Specification impurity results obtained during routine t... Class II SigmaPharm Laboratories LLC
Aug 13, 2021 FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.