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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 3,301–3,320 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recall initiated
October 7, 2022
Reported by FDA
November 9, 2022
Distribution
AL, LA, MS, and TN

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Drug Recall Ongoing Historical recordClass II

ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recall initiated
October 7, 2022
Reported by FDA
November 9, 2022
Distribution
AL, LA, MS, and TN

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Drug Recall Ongoing Historical recordClass II

ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recall initiated
October 7, 2022
Reported by FDA
November 9, 2022
Distribution
AL, LA, MS, and TN

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Drug Recall Terminated Historical recordClass III

Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990.

by Genentech Inc

Reason
Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
Recall initiated
October 18, 2022
Reported by FDA
November 9, 2022
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Presence of Foreign Substance
Recall initiated
October 18, 2022
Reported by FDA
November 9, 2022
Distribution
Nationwide with the United States

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Drug Recall Terminated Historical recordClass I

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.

by Exela Pharma Sciences LLC

Reason
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Recall initiated
October 4, 2022
Reported by FDA
November 2, 2022
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass I

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1

by Exela Pharma Sciences LLC

Reason
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Recall initiated
October 4, 2022
Reported by FDA
November 2, 2022
Distribution
Nationwide within the United States

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Drug Recall Completed Historical recordClass II

Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Recall initiated
October 5, 2022
Reported by FDA
November 2, 2022
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10

by Golden State Medical Supply Inc.

Reason
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Recall initiated
September 29, 2022
Reported by FDA
November 2, 2022
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01

by VistaPharm, Inc.

Reason
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Recall initiated
September 30, 2022
Reported by FDA
November 2, 2022
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.

by Ultra Chem Labs Corp

Reason
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Recall initiated
August 15, 2022
Reported by FDA
November 2, 2022
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.

by Ultra Chem Labs Corp

Reason
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Recall initiated
August 15, 2022
Reported by FDA
November 2, 2022
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe)

by AuroMedics Pharma LLC

Reason
Subpotent Drug: Out of specification for assay
Recall initiated
September 30, 2022
Reported by FDA
November 2, 2022
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10

by Fresenius Medical Care Holdings, Inc.

Reason
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Recall initiated
October 11, 2022
Reported by FDA
October 26, 2022
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com

by LNK International, Inc.

Reason
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Recall initiated
October 11, 2022
Reported by FDA
October 26, 2022
Distribution
Nationwide

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Drug Recall Completed Historical recordClass II

Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.

by AuroMedics Pharma LLC

Reason
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Recall initiated
September 26, 2022
Reported by FDA
October 26, 2022
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC 51407-322-30

by Golden State Medical Supply Inc.

Reason
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Recall initiated
October 6, 2022
Reported by FDA
October 26, 2022
Distribution
USA nationwide

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Drug Recall Terminated Historical recordClass II

Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.

by Golden State Medical Supply Inc.

Reason
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Recall initiated
October 6, 2022
Reported by FDA
October 26, 2022
Distribution
USA nationwide

View recall →

Drug Recall Completed Historical recordClass II

Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7

by Ingenus Pharmaceuticals Llc

Reason
Out of specification for related substances (impurities).
Recall initiated
September 30, 2022
Reported by FDA
October 26, 2022
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8

by Justified Laboratories

Reason
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Recall initiated
September 9, 2022
Reported by FDA
October 19, 2022
Distribution
United States including Puerto Rico and Canada

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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.