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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 13,621–13,640 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Recall initiated
July 15, 2015
Reported by FDA
August 19, 2015
Distribution
Nationwide, Puerto Rico & Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Recall initiated
July 15, 2015
Reported by FDA
August 19, 2015
Distribution
Nationwide, Puerto Rico & Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,NDC 99999-2011-17

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13389-1152-36

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1747-39

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2913-85

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-1540-18

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2348-22

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

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.