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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 5,041–5,060 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10

by Spirit Pharmaceuticals

Reason
cGMP deviations: Discolored acetaminophen
Recall initiated
June 16, 2021
Reported by FDA
August 25, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711

by DuPont Nutrition USA, Inc

Reason
Out of specification results for conductivity.
Recall initiated
August 5, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed nationwide, including Puerto Rico and to foreign accounts abroad.

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Drug Recall Terminated Historical recordClass II

Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4

by High Performance Formulas, L.L.C. (HPF, L.L.C.)

Reason
Marketed Without an Approved NDA/ANDA
Recall initiated
July 26, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19

by Novel Laboratories, Inc. d.b.a LUPIN

Reason
Failed Stability Specification; Out of specification for Osmolarity
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186

by Noven Pharmaceuticals Inc

Reason
Failed Stability Specifications; out of specification for shear.
Recall initiated
July 30, 2021
Reported by FDA
August 25, 2021
Distribution
Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186

by Noven Pharmaceuticals Inc

Reason
Failed Stability Specifications; out of specification for shear.
Recall initiated
July 30, 2021
Reported by FDA
August 25, 2021
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16

by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Reason
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Recall initiated
July 29, 2021
Reported by FDA
August 18, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08

by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Reason
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Recall initiated
July 29, 2021
Reported by FDA
August 18, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605

by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Reason
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Recall initiated
July 29, 2021
Reported by FDA
August 18, 2021
Distribution
Distributed 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.