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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 6,261–6,280 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Age Back, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808

by Herbal Doctor Remedies

Reason
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Recall initiated
March 24, 2020
Reported by FDA
April 15, 2020
Distribution
Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom

View recall →

Drug Recall Terminated Historical recordClass II

Acne Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

by Herbal Doctor Remedies

Reason
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Recall initiated
March 24, 2020
Reported by FDA
April 15, 2020
Distribution
Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom

View recall →

Drug Recall Terminated Historical recordClass II

Acne Cystic, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

by Herbal Doctor Remedies

Reason
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Recall initiated
March 24, 2020
Reported by FDA
April 15, 2020
Distribution
Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom

View recall →

Drug Recall Terminated Historical recordClass II

Acupuncture, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

by Herbal Doctor Remedies

Reason
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Recall initiated
March 24, 2020
Reported by FDA
April 15, 2020
Distribution
Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816

by Avet Pharmaceuticals, Inc.

Reason
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Recall initiated
March 26, 2020
Reported by FDA
April 15, 2020
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09

by Avet Pharmaceuticals, Inc.

Reason
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Recall initiated
March 26, 2020
Reported by FDA
April 15, 2020
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated
March 25, 2020
Reported by FDA
April 15, 2020
Distribution
Bulk product was distributed to one re-packager in California.

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Drug Recall Ongoing Historical recordClass II

LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated
March 25, 2020
Reported by FDA
April 15, 2020
Distribution
Bulk product was distributed to one re-packager in California.

View recall →

Drug Recall Ongoing Historical recordClass II

LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated
March 25, 2020
Reported by FDA
April 15, 2020
Distribution
Bulk product was distributed to one re-packager in California.

View recall →

Drug Recall Terminated Historical recordClass II

Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

by Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
March 26, 2020
Reported by FDA
April 15, 2020
Distribution
Patient Distribution list includes addresses in the following states: CA, ME, TX

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

by Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
March 26, 2020
Reported by FDA
April 15, 2020
Distribution
Patient Distribution list includes addresses in the following states: CA, ME, TX

View recall →

Drug Recall Terminated Historical recordClass II

Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

by Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
March 26, 2020
Reported by FDA
April 15, 2020
Distribution
Patient Distribution list includes addresses in the following states: CA, ME, TX

View recall →

Drug Recall Terminated Historical recordClass II

MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

by Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
March 26, 2020
Reported by FDA
April 15, 2020
Distribution
Patient Distribution list includes addresses in the following states: CA, ME, TX

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

by Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
March 26, 2020
Reported by FDA
April 15, 2020
Distribution
Patient Distribution list includes addresses in the following states: CA, ME, TX

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recall initiated
March 16, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recall initiated
March 16, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recall initiated
March 16, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recall initiated
March 16, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recall initiated
March 16, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recall initiated
March 16, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed 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.