Skip to main content
Get Alerts

FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

Filters
Recall details
Location
Date range
Clear filters

Showing 4,881–4,900 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass I

ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)

by Alpha-Tek LLC

Reason
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Recall initiated
July 16, 2021
Reported by FDA
October 13, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14

by SigmaPharm Laboratories LLC

Reason
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Recall initiated
September 21, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1

by IntegraDose Compounding Services LLC

Reason
Lack of sterility assurance.
Recall initiated
September 17, 2021
Reported by FDA
October 6, 2021
Distribution
NH, MA, MN

View recall →

Drug Recall Terminated Historical recordClass II

Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Aconitum nap Fear* 20% Alcohol HPUS: 6X, packaged in 50mL & 8 oz containers Aconitum nap Fear* 20% Alcohol HPUS: 7X, 12X, packaged in 15mL containers WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X, 9X, 12X,30X, packaged in 1 oz containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 10X, 15X, 24X, 30X, packaged in 2 dr containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 30X, packaged in 2 oz containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 7X, 8X, 10X, 12X, 15X, 16X, 18X, 30X, packaged in 4 dram containers, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 6X, 26X, 30X, packaged in 15mL containers, Aconitum Napellus Fear* 20% Alcohol HPUS: 6X, 10X, packaged in 30mL containers Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 10X, 12X, 30X, packaged in 50mL containers Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, packaged in 100mL containers WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Strophanthus hisp 30X, Hives*, Sucrose/Lactose Pills , Packaged in (a) 2 dr, UPC 7 40640 47533 1; (b) 4 dr UPC 7 40640 47537 9; (c) 1 oz, UPC 7 40640 47541 6; (d) 2 oz, UPC 7 40640 47545 4; WHP Homeopathic Mecicine, 260 JR Hawvermale Way, Berkeley Springs, WV 25411

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Strophanthus hisp 30X, Hives*, 20% Alcohol, Packaged in (a) 15 mL, UPC 7 40640 47553 9; (b) 30mL UPC 7 40640 47557 7; (c) 100mL, UPC 7 40640 47565 2; WHP Homeopathic Mecicine, 260 JR Hawvermale Way, Berkeley Springs, WV 25411

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus Toxicodendron 10X, Aurum Metallicum 10X, Iris Versicolor 10X, Lycopodium Clavatum 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%, Manufactured for Optimal Health Dimensions, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 25411,

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Z-1070 Formula Anxioheal. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY:Causticum 30X, Conium Maculatum 8X, Conium Maculatum 12X, Crataegus Oxyacantha 12X, Crataegus Oxyacantha 30X, Ignatia Amara 24X, Lycopus Virginicus 12X, Phosphoricum Acidum 12X, Phosphoricum Acidum 24X, Rhus Toxicodendron 24X, Secale Cornutum 24X, Secale Cornutum 30X, Sepia 6X, Sepia 24X, Solanum Nigrum 30X, Zincum Valericanicum 8X, Zincum Valerianicum 12X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only. anufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Z-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Cholesterinum 10X, Avena Sativa 12X, Cynara Scolymos 12X, Phosphorus 12X, Oroticum Acidum 13X, Aesculus Hipposcastanum 24X, Carduus Marianus 24X, Chelidonium Majus 24X, Cimicifuga Racemosa 24X, Cinchona Officinalis 24X, Colocynthis 24X, Histaminum Hydrochloricum 24X, Lycopodium Clavatum 24X, Sulphur 24X, Tataxacum Officinale 24X, Veratrum Album 24X, Sepia 30X, Strontium Carbonicum 30X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only. anufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Z-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Baryta Carbonica 10X, Chromium Sulphuricum 10X, Crataegus Oxyacantha 10X, Digitalis Purpurea 10X, Manganum Metallicum 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Crataegus Oxyacantha 10X, Baryta Carbonica 10X, Digitalis Purpurea 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only, Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Z-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Only, REMEDY: Amygdalus Persica 10X, Arnica Montana 10X, Bellis Perennis 10X, Chromium Sulphuricum 10X, Citrus Vulgaris 10X, Derris Pinnata 13X, Franciscea Uniflora 13X, Hamamelis Virginiana 10X, Manganum Metallicum 10X, Ruta Graveolens 10X, Sarsaparilla 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensi. RX Only, Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine. For Manufacturing Use Only, REMEDY: Agrimonia Eupatoria 24X, Alfalfa 24X, Althaea Officinalis 24X, Avena Sativa 24X, Boldo 24X, Carduus Marianus 24X, Chioanathus Virginica 24X, Cynara Scolymus 24X, Iria Versicolor 24X, Millefolium 24X, Rumex Crispus 24X, Selenium Metallicum 12X, Selenium Metallicum 60X, Solidago Virgaurea 12X, Solidago Virgaurea 24X, Solidago Virgaurea 60X, Spiraea Ulmaira 24X, Taraxacum Officinale 24X, Urtica Dioica 24X, Uva-Ursi 24X, Zincum Muriaticum 13X, Zincum Mruiaticum 30X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensi. RX Only, Manufactured by Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Viola od 6X, 30X, Bee Stings*, Sucrose/Lactose Pills, 6X Packaged in a) 4 Dram, UPC 7 40640 50139 9; 30X Packaged in b) 4 dr, UPC 7 40640 50141 2; c) 2 oz, UPC 7 40640 50149 8; WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Quebracho 4C, Fever*, 20% Alcohol, Packaged as 100ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Cistus Canadensis 5X Coldness* 20% Alcohol drops, Packaged in a) 15ml; b) 50 ml; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Althaea 30X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.

by Washington Homeopathic Products, Inc.

Reason
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Recall initiated
August 20, 2021
Reported by FDA
October 6, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.