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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 3,521–3,540 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734

by Aire-Master of America Inc

Reason
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Recall initiated
July 15, 2022
Reported by FDA
August 24, 2022
Distribution
Florida, Illinois, Iowa, New Jersey

View recall →

Drug Recall Terminated Historical recordClass II

Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606

by Aire-Master of America Inc

Reason
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Recall initiated
July 15, 2022
Reported by FDA
August 24, 2022
Distribution
Florida, Illinois, Iowa, New Jersey

View recall →

Drug Recall Terminated Historical recordClass II

Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.

by Aire-Master of America Inc

Reason
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Recall initiated
July 15, 2022
Reported by FDA
August 24, 2022
Distribution
Florida, Illinois, Iowa, New Jersey

View recall →

Drug Recall Terminated Historical recordClass II

Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440

by Aire-Master of America Inc

Reason
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Recall initiated
July 15, 2022
Reported by FDA
August 24, 2022
Distribution
Florida, Illinois, Iowa, New Jersey

View recall →

Drug Recall Terminated Historical recordClass II

Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253

by Aire-Master of America Inc

Reason
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Recall initiated
July 15, 2022
Reported by FDA
August 24, 2022
Distribution
Florida, Illinois, Iowa, New Jersey

View recall →

Drug Recall Terminated Historical recordClass II

Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253

by Aire-Master of America Inc

Reason
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Recall initiated
July 15, 2022
Reported by FDA
August 24, 2022
Distribution
Florida, Illinois, Iowa, New Jersey

View recall →

Drug Recall Terminated Historical recordClass II

Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01

by Nephron Sc Inc

Reason
cGMP Deviations: deviations leading to potential cross-contamination.
Recall initiated
August 10, 2022
Reported by FDA
August 24, 2022
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass III

Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ

by Akron Pharma, Inc.

Reason
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Recall initiated
August 4, 2022
Reported by FDA
August 24, 2022
Distribution
Product was distributed to 6 distributors/wholesalers who may have further distributed the product.

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Drug Recall Terminated Historical recordClass III

Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ

by Akron Pharma, Inc.

Reason
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Recall initiated
August 4, 2022
Reported by FDA
August 24, 2022
Distribution
Product was distributed to 6 distributors/wholesalers who may have further distributed the product.

View recall →

Drug Recall Terminated Historical recordClass II

Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed Impurities/Degradation Specifications
Recall initiated
July 15, 2022
Reported by FDA
August 24, 2022
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass III

Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56

by Amerisource Health Services LLC

Reason
Subpotent Drug
Recall initiated
July 27, 2022
Reported by FDA
August 24, 2022
Distribution
Nationwide within the USA

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60

by Baxter Healthcare Corporation

Reason
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
Recall initiated
August 4, 2022
Reported by FDA
August 24, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34

by Nephron Sterile Compounding Center LLC

Reason
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Recall initiated
August 10, 2022
Reported by FDA
August 24, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05

by Nephron Sterile Compounding Center LLC

Reason
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Recall initiated
August 10, 2022
Reported by FDA
August 24, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04

by Nephron Sterile Compounding Center LLC

Reason
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Recall initiated
August 10, 2022
Reported by FDA
August 24, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33

by Nephron Sterile Compounding Center LLC

Reason
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Recall initiated
August 10, 2022
Reported by FDA
August 24, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Recall initiated
July 28, 2022
Reported by FDA
August 24, 2022
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass I

M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC Code: 77797-001-01, Distributed by: Medek, LLC 315 E. Business Hwy 83 Alamo, TX 78516, NDC Code: 75432-001-02.

by MEDEK LLC

Reason
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Recall initiated
September 9, 2020
Reported by FDA
August 24, 2022
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass III

Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02

by HERON THERAPEUTICS, INC.

Reason
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Recall initiated
August 2, 2022
Reported by FDA
August 24, 2022
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56

by Teva Pharmaceuticals USA Inc

Reason
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Recall initiated
July 22, 2022
Reported by FDA
August 17, 2022
Distribution
Distributed in Ohio

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.