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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 9,421–9,440 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-10

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-905-10

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix AZ 85085. NDC 42852-729-25

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX 77054. NDC 15082-210-70

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-823-25.

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25.

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX 77054 NDC: 42852-604-10

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat. India, NDC 62756-142-02

by Sun Pharmaceutical Industries, Inc.

Reason
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Recall initiated
July 3, 2018
Reported by FDA
July 25, 2018
Distribution
AZ

View recall →

Drug Recall Terminated Historical recordClass II

Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500

by La Vita Compounding Pharmacy, LLC

Reason
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Recall initiated
June 25, 2018
Reported by FDA
July 25, 2018
Distribution
Product was distributed to patients via patient specific prescription only in CA.

View recall →

Drug Recall Terminated Historical recordClass II

Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500

by La Vita Compounding Pharmacy, LLC

Reason
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Recall initiated
June 25, 2018
Reported by FDA
July 25, 2018
Distribution
Product was distributed to patients via patient specific prescription only in CA.

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500

by La Vita Compounding Pharmacy, LLC

Reason
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Recall initiated
June 25, 2018
Reported by FDA
July 25, 2018
Distribution
Product was distributed to patients via patient specific prescription only in CA.

View recall →

Drug Recall Terminated Historical recordClass II

alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4.

by The Hain Celestial Group, Inc. - Worldwide HQ

Reason
Incorrect Product Formulation: wrong sunscreen product in the package.
Recall initiated
July 5, 2018
Reported by FDA
July 25, 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.