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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 4,421–4,440 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Recall initiated
January 18, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.

by Dental Alliance Holdings LLC

Reason
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Recall initiated
December 3, 2021
Reported by FDA
February 2, 2022
Distribution
Distributed nationwide with the United States

View recall →

Drug Recall Terminated Historical recordClass III

CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.

by Dental Alliance Holdings LLC

Reason
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Recall initiated
December 3, 2021
Reported by FDA
February 2, 2022
Distribution
Distributed nationwide with the United States

View recall →

Drug Recall Terminated Historical recordClass III

CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.

by Dental Alliance Holdings LLC

Reason
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Recall initiated
December 3, 2021
Reported by FDA
February 2, 2022
Distribution
Distributed nationwide with the United States

View recall →

Drug Recall Terminated Historical recordClass III

CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.

by Dental Alliance Holdings LLC

Reason
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Recall initiated
December 3, 2021
Reported by FDA
February 2, 2022
Distribution
Distributed nationwide with the United States

View recall →

Drug Recall Terminated Historical recordClass III

CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.

by Dental Alliance Holdings LLC

Reason
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Recall initiated
December 3, 2021
Reported by FDA
February 2, 2022
Distribution
Distributed nationwide with the United States

View recall →

Drug Recall Terminated Historical recordClass III

CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.

by Dental Alliance Holdings LLC

Reason
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Recall initiated
December 3, 2021
Reported by FDA
February 2, 2022
Distribution
Distributed nationwide with the United States

View recall →

Drug Recall Terminated Historical recordClass III

CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 Distributed in 12-pk/cases

by Dental Alliance Holdings LLC

Reason
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Recall initiated
December 3, 2021
Reported by FDA
February 2, 2022
Distribution
Distributed nationwide with the United States

View recall →

Drug Recall Terminated Historical recordClass II

Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120, NDC 0037-6822-10.

by MYLAN PHARMACEUTICALS INC

Reason
cGMP deficiencies
Recall initiated
January 21, 2022
Reported by FDA
February 2, 2022
Distribution
Recalled product was distributed nationwide within the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03

by American Health Packaging

Reason
Failed Dissolution Specifications
Recall initiated
December 20, 2021
Reported by FDA
February 2, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05

by Aurobindo Pharma USA Inc.

Reason
Superpotent and Failed Tablet/Capsule Specifications
Recall initiated
December 29, 2021
Reported by FDA
February 2, 2022
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1132-03

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1045-03

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0408-10

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

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.