Skip to main content

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 10,141–10,160 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product in a can, NET WT. 5 OZ (141 g) , Distributed by Johnson & Johnson Consumer Inc. Skillman, NJ 08558, UPC 0 70501 11131 4

by Johnson & Johnson

Reason
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Recall initiated
December 7, 2017
Reported by FDA
February 7, 2018
Distribution
Product was distributed nationwide

View recall →

Drug Recall Terminated Historical recordClass II

SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47

by Boehringer Ingelheim Pharmaceuticals, Inc.

Reason
Failed Stability Specifications
Recall initiated
December 14, 2017
Reported by FDA
February 7, 2018
Distribution
Distributed nationwide

View recall →

Drug Recall Terminated Historical recordClass I

MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10

by Advanced Pharma Inc.

Reason
Subpotent
Recall initiated
January 5, 2018
Reported by FDA
January 31, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass I

BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481

by BotanicalNow

Reason
Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
Recall initiated
December 7, 2017
Reported by FDA
January 31, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA

by www.blankterrmall.com

Reason
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
Recall initiated
November 19, 2017
Reported by FDA
January 31, 2018
Distribution
Product was distributed in the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond Oil, 8 fl. oz. (237 mL) HPDE bottle, Distributed by: Earth's Care Natural Products, Inc. Long Beach, California 90805, NDC 24286-1569-08, UPC 85730700307.

by DLC Laboratories, Inc

Reason
Microbial Contamination of Non-Sterile Products.
Recall initiated
December 28, 2017
Reported by FDA
January 31, 2018
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-123-27.

by Marksans Pharma Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 9, 2018
Reported by FDA
January 31, 2018
Distribution
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-121-29.

by Marksans Pharma Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 9, 2018
Reported by FDA
January 31, 2018
Distribution
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-114-30.

by Marksans Pharma Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 9, 2018
Reported by FDA
January 31, 2018
Distribution
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-136-20.

by Marksans Pharma Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 9, 2018
Reported by FDA
January 31, 2018
Distribution
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-117-30.

by Marksans Pharma Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 9, 2018
Reported by FDA
January 31, 2018
Distribution
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser carton, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-926-16.

by International Laboratories, Inc.

Reason
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Recall initiated
January 12, 2018
Reported by FDA
January 31, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser cartons, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-927-16.

by International Laboratories, Inc.

Reason
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Recall initiated
January 12, 2018
Reported by FDA
January 31, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml / 2 oz), Night Cream (15 g / 0.5 oz), Day Cream SPF15 {Octinoxate 7%, Avobenzone 2% and Oxybenzone 5%} (15 g / 0.5 oz), Eye Cream (6 g / 0.21 oz).Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics (USA) Inc. 99 Hudson, New York, NY, USA. UPC code 6 06354 61322 4

by Odan Laboratories Ltd

Reason
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Recall initiated
December 20, 2017
Reported by FDA
January 31, 2018
Distribution
distributed nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics Montreal, Quebec H9R 2Y6 Made in Fabrique au Canada. UPC code 6 26354 10955 0

by Odan Laboratories Ltd

Reason
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Recall initiated
December 20, 2017
Reported by FDA
January 31, 2018
Distribution
distributed nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05

by Mylan Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
Recall initiated
November 3, 2017
Reported by FDA
January 31, 2018
Distribution
Product was distributed nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries , Inc. Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway. Halol-389 350, Gujarat, India. NDC 47335-049-40

by Sun Pharmaceutical Industries, Inc.

Reason
Lack Of Assurance Of Sterility
Recall initiated
January 16, 2018
Reported by FDA
January 31, 2018
Distribution
Product was distributed nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28.

by Marksans Pharma Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 9, 2018
Reported by FDA
January 31, 2018
Distribution
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01

by UNICHEM PHARMACEUTICALS USA INC

Reason
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Recall initiated
December 19, 2017
Reported by FDA
January 24, 2018
Distribution
Product was distributed nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FL

by Pharmatech LLC

Reason
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Recall initiated
August 16, 2017
Reported by FDA
January 24, 2018
Distribution
MI

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.