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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.

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Showing 4,901–4,920 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Althaea 6X, Iritable Bladder* 20% Alcohol, Drops, packaged as 15 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 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 1 OZ, 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 Officinalis 6X, 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 →

Drug Recall Terminated Historical recordClass II

La Core LCL-2-0191 Blend, 149,980ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Only, Liter LCL-2-0191-Bend: 12% Lycopodium Clavatum 10X, 12% Carbo Vegetabilis 16X, 12% Natrum Muriaticum 9X, 12% Calcarea Carbonica 12X, 10% Hypothalamus 30X, 6% Pituitarum Posterium 12X, 6% Pituitarum Posterium 30C, 3% Natrum Phosphoricum 12X, 3% Graphites 30X, 3# Agnus Castus 6X, 3% Thiosinaminum 8X, 3% Phytolacca Decandra 12X, 3% Magnesia Phosphorica 10X, 3% Ornithogalum Umbellatum 6X, 3% Chelidonium Majus 6X, 3% Quercus Robur 14X, 3% Nux Vomica 30X, 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

Quebracho 4C, 5C, 6C, 12C, 30C, Fever*, Sucrose/Lactose Pills, 5C Packaged as a) 4dr; 6C Packaged as b) 4 Dram UPC 7 40640 44092 6; c) 2 oz UPC 7 40640 44100 8; 12C Packaged as d) 4 Dram; e) 2 oz; 30C Packaged as f) 2 dr UPC 7 40640 44090 2; g) 4 Dram, UPC 7 40640 44094 0; h) 1 oz, UPC 7 40640 44098 8; i) 2 oz, UPC 7 40640 44102 2; 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 6X, 10X, 15X, 30X, Coldness* Sucrose/Lactose Pills, 6X Packaged as a) 1 OZ, UPC 7 40640 28177 2, b) 4 dr, UPC 7 40640 28173 4; 10X Packaged as c) 4 dr; 15X Packaged as d) 1 OZ; 30X Packaged as e) 2 Dram, UPC 7 40640 28171 0, f) 4 dr, UPC 7 40640 28175 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

Cinnamomum 6X, Flatulence* Sucrose/Lactose Pills, Packaged as a) 4 Dram, b) 1 oz, and Cinnamomum 30X, Flatulence* 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 →

Drug Recall Terminated Historical recordClass II

Althaea Officinalis 4X, Iritable Bladder* packaged as Sucrose/Lactose Pills, 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 →

Drug Recall Terminated Historical recordClass II

Haloderm Homeopathic Blend, For Manufacturing Use Only, 1,000 ml 20% Alcohol, Contains: Dulcamara 10x, Nitricum Acidum 12x, Thuja Occidentalis 10x, Antimonium Crudum 12x, Calcarea Cadbonica 12x, Silicea 12x, WHP Homeopathic Medicine, FOr Manufacturing Use Only. 1.957 kg Lactose Manufactured by Wasington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411. Marketed by: Health Specialty

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

Yeast Guard Blend, Calcarea Carbonica 6X, Collinsonia Canadensis 3X, Kali Muriaicum 3X, WHP Homeopathic Medicine, For Manufacturing Use Only. 1.957 kg Lactose, Manufactured by Wasington 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

Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01

by Monarch PCM, LLC

Reason
Finished product specification did not meet USP specifications.
Recall initiated
September 23, 2021
Reported by FDA
October 6, 2021
Distribution
TN

View recall →

Drug Recall Terminated Historical recordClass II

Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42

by American Health Packaging

Reason
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Recall initiated
September 15, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass III

Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

by New Vision Pharmaceuticals LLC

Reason
Subpotent Drug
Recall initiated
September 2, 2021
Reported by FDA
October 6, 2021
Distribution
AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01

by Viatris

Reason
Failed Dissolution Specifications
Recall initiated
August 23, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255 6

by Johnson & Johnson Consumer, Inc.

Reason
cGMP Deviations
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

View recall →

Drug Recall Ongoing Historical recordClass II

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858 UPC 0 86800 10048 5

by Johnson & Johnson Consumer, Inc.

Reason
cGMP Deviations
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

View recall →

Drug Recall Ongoing Historical recordClass II

Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 8.0 oz. (226 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 11133 7

by Johnson & Johnson Consumer, Inc.

Reason
cGMP Deviations
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

View recall →

Drug Recall Ongoing Historical recordClass II

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), a) NET WT. 6.5 OZ. (184 g) (UPC 0 86800 87274 0) and b) NET WT. 8.5 OZ. (240 g) (UPC 0 86800 10048 5) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858

by Johnson & Johnson Consumer, Inc.

Reason
cGMP Deviations
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

View recall →

Drug Recall Ongoing Historical recordClass I

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255 6

by Johnson & Johnson Consumer, Inc.

Reason
Chemical Contamination: presence of benzene
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

View recall →

Drug Recall Ongoing Historical recordClass I

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254 9

by Johnson & Johnson Consumer, Inc.

Reason
Chemical Contamination: presence of benzene
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

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.