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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 8,921–8,940 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass III

Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0104-55

by Right Value Drug Stores, Inc.

Reason
Labeling Not Elsewhere Classified: Misbranding.
Recall initiated
September 25, 2018
Reported by FDA
November 21, 2018
Distribution
Distributed in California

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Drug Recall Terminated Historical recordClass II

Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02

by Silver Star Brands

Reason
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Recall initiated
October 3, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-204-02

by Silver Star Brands

Reason
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Recall initiated
October 3, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass I

Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-151-59

by Silver Star Brands

Reason
Microbial Contamination of Non-Sterile Product
Recall initiated
October 3, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass I

Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-275-02

by Silver Star Brands

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
October 3, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass I

Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02

by Silver Star Brands

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
October 3, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA

by Medline Industries Inc

Reason
Microbial Contamination of Non-Sterile Product
Recall initiated
September 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix, AZ 85085. NDC 42852-001-24

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility
Recall initiated
October 31, 2018
Reported by FDA
November 14, 2018
Distribution
Product was distributed throughout the United States.

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Drug Recall Terminated Historical recordClass II

Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356

by Tailor Made Compounding

Reason
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
Recall initiated
September 28, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27.

by S.C. Johnson Professional

Reason
CGMP Deviations: Product was released to market prior to microbiological testing.
Recall initiated
October 26, 2018
Reported by FDA
November 14, 2018
Distribution
NC

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Drug Recall Terminated Historical recordClass III

Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99

by Orexigen Therapeutics, Inc.

Reason
Container packaging defect.
Recall initiated
October 5, 2018
Reported by FDA
November 14, 2018
Distribution
Within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day Regimen per pouch, packaged in a) 6 Veridate Tablet Dispensers and 6 Refill pouches (NDC 504-58-178-28) per carton (NDC 50458-178-06); and b) 12 Veridate Tablet Dispenser Refills (NDC 50458-178-12) per carton (NDC 50458-178-12), Clinic Package, , Rx Only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560.

by Janssen Pharmaceuticals, Inc.

Reason
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Recall initiated
October 23, 2018
Reported by FDA
November 14, 2018
Distribution
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.