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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 10,581–10,600 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40

by SCA Pharmaceuticals

Reason
Lack of sterility assurance
Recall initiated
June 21, 2017
Reported by FDA
July 19, 2017
Distribution
LA, PA, NY, WI

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Drug Recall Terminated Historical recordClass II

Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32

by SCA Pharmaceuticals

Reason
Lack of sterility assurance
Recall initiated
June 21, 2017
Reported by FDA
July 19, 2017
Distribution
LA, PA, NY, WI

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Drug Recall Terminated Historical recordClass II

Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40

by SCA Pharmaceuticals

Reason
Lack of sterility assurance
Recall initiated
June 21, 2017
Reported by FDA
July 19, 2017
Distribution
LA, PA, NY, WI

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Drug Recall Terminated Historical recordClass II

Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40

by SCA Pharmaceuticals

Reason
Lack of sterility assurance
Recall initiated
June 21, 2017
Reported by FDA
July 19, 2017
Distribution
LA, PA, NY, WI

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Drug Recall Terminated Historical recordClass II

CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.3 oz (207g) tubes, OTC, Distributed by CVS Pharmacy Inc., Woonsocket, RI --- UPC 050428568033

by Sigan Industries Inc.

Reason
Microbial Contamination of Non Sterile Products; out of specification Total Plate Count
Recall initiated
June 13, 2017
Reported by FDA
July 19, 2017
Distribution
CA

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Drug Recall Terminated Historical recordClass III

Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06

by Lupin Pharmaceuticals Inc.

Reason
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Recall initiated
June 22, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Bags have the potential to leak.
Recall initiated
July 6, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide, Puerto Rico and Saudi Arabia

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Drug Recall Terminated Historical recordClass II

5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Bags have the potential to leak.
Recall initiated
July 6, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide, Puerto Rico and Saudi Arabia

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Drug Recall Terminated Historical recordClass I

LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY --- UPC Code 680474228904

by Organic Herbal Supply

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall initiated
April 18, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide via internet

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Drug Recall Terminated Historical recordClass I

ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 680474229055

by Organic Herbal Supply

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall initiated
April 18, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide via internet

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Drug Recall Terminated Historical recordClass I

ENHANCEROL Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086

by Organic Herbal Supply

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall initiated
April 18, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide via internet

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Drug Recall Terminated Historical recordClass I

BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086

by Organic Herbal Supply

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall initiated
April 18, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide via internet

View recall →

Drug Recall Terminated Historical recordClass I

ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 680474229062

by Organic Herbal Supply

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall initiated
April 18, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide via internet

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Drug Recall Terminated Historical recordClass I

TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied in 2, 4 and 10 count packages, Made in USA Distributed by American Health Supplements, Chicago, Illinois --- UPC Code 680474228959

by Organic Herbal Supply

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall initiated
April 18, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide via internet

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Drug Recall Terminated Historical recordClass I

RECTALIS Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY --- UPC Code 680474228782

by Organic Herbal Supply

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall initiated
April 18, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide via internet

View recall →

Drug Recall Terminated Historical recordClass I

Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA ---- UPC Code 680474015795

by Organic Herbal Supply

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall initiated
April 18, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide via internet

View recall →

Drug Recall Terminated Historical recordClass I

ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 852675999451

by Organic Herbal Supply

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall initiated
April 18, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide via internet

View recall →

Drug Recall Terminated Historical recordClass I

Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV --- UPC code #680474229116

by Organic Herbal Supply

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall initiated
April 18, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide via internet

View recall →

Drug Recall Terminated Historical recordClass I

UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, supplied in 2, 4 and 10 count packages, Distributed by AH Distribution, DelRay, Beach, FL ---- UPC Code 680474229260

by Organic Herbal Supply

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall initiated
April 18, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide via internet

View recall →

Drug Recall Terminated Historical recordClass I

Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19

by Teva Pharmaceuticals

Reason
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Recall initiated
May 31, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide in the 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.