Recall feed

Recent FDA recalls

Across drugs, devices, supplements and cosmetics. Most recent first. Source: openFDA enforcement.

showing 100 of 100

Date ↓	Substance	Class	Reason	Firm
Sep 5, 2014	glutathione	I	Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.	Pharmacy Creations
Sep 21, 2016	glutathione	II	Lack of Assurance of Sterility	Wells Pharmacy Network LLC
Sep 12, 2019	glutathione	II	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc
Sep 10, 2018	glutathione	II	Lack of Assurance of Sterility	Pharm D Solutions, LLC
Oct 6, 2014	glutathione	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Oregon Compounding Centers, Inc. dba Creative Compounds
Oct 6, 2014	glutathione	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Oregon Compounding Centers, Inc. dba Creative Compounds
Oct 19, 2017	bimatoprost	III	Failed Impurities/Degradation Specifications.	Allergan Sales, LLC
Oct 19, 2015	glutathione	II	Lack of Assurance of Sterility	Western Drug
Oct 19, 2015	glutathione	II	Lack of Assurance of Sterility	Western Drug
Oct 19, 2013	glutathione	II	Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.	Specialty Medicine Compounding Pharmacy
Oct 16, 2015	glutathione	II	Lack of Assurance of Sterility	Downing Labs, LLC
Nov 30, 2020	copper peptide	II	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.	Advanced Nutriceuticals, LLC
Nov 22, 2023	nicotinamide	II	Presence of Particulate Matter.	AnazaoHealth Corporation
Nov 17, 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
Nov 17, 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
Nov 17, 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
Nov 17, 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
Nov 17, 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
Nov 17, 2016	glutathione	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
Nov 17, 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
Nov 17, 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
Nov 1, 2013	glutathione	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Natures Pharmacy & Compounding Center
Nov 1, 2013	glutathione	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Natures Pharmacy & Compounding Center
Nov 1, 2013	glutathione	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Natures Pharmacy & Compounding Center
Nov 1, 2013	glutathione	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Natures Pharmacy & Compounding Center
May 9, 2022	nicotinamide	II	Lack of assurance of sterility.	Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022	nicotinamide	II	Lack of assurance of sterility.	Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022	glutathione	II	Lack of assurance of sterility.	Olympia Compounding Pharmacy dba Olympia Pharmacy
May 24, 2022	nicotinamide	II	Lack of Assurance of Sterility	US Specialty Formulations LLC
May 23, 2019	nicotinamide	II	Lack of Sterility Assurance.	Pharm D Solutions, LLC
May 18, 2015	glutathione	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
May 17, 2018	glutathione	II	Lack of sterility assurance.	Guardian Pharmacy Services
May 17, 2018	glutathione	II	Lack of sterility assurance.	Guardian Pharmacy Services
May 17, 2018	glutathione	II	Lack of sterility assurance.	Guardian Pharmacy Services
May 17, 2016	glutathione	II	Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.	Well Care Compounding Pharmacy
May 17, 2016	glutathione	II	Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.	Well Care Compounding Pharmacy
May 15, 2015	glutathione	II	Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection	Montana Compounding Pharmacy
May 15, 2015	glutathione	II	Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection	Montana Compounding Pharmacy
May 13, 2016	nicotinamide	II	Lack of Assurance of Sterility	Medaus, Inc.
May 13, 2016	glutathione	II	Lack of Assurance of Sterility	Medaus, Inc.
Mar 7, 2022	glutathione	II	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022	glutathione	II	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding
Mar 22, 2018	glutathione	II	Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.	Partell Specialty Pharmacy
Mar 16, 2017	bimatoprost	III	Failed Impurities/Degradation Specifications	Allergan Sales, LLC
Mar 15, 2021	semaglutide	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
Jun 26, 2019	glutathione	II	Lack of Assurance of Sterility.	First Pharma Associates LLC dba Riverpoint Pharmacy
Jun 25, 2018	glutathione	II	Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.	La Vita Compounding Pharmacy, LLC
Jun 25, 2014	glutathione	II	Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer	Medical Supply Liquidators Llc
Jun 2, 2015	glutathione	II	Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility	The Compounding Pharmacy of America
Jun 2, 2015	glutathione	II	Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility	The Compounding Pharmacy of America
Jun 19, 2019	glutathione	II	Lack of Assurance of Sterility	RXQ Compounding LLC
Jun 19, 2019	nicotinamide	II	Lack of Assurance of Sterility	RXQ Compounding LLC
Jun 19, 2019	glutathione	II	Lack of Assurance of Sterility	RXQ Compounding LLC
Jul 30, 2025	glutathione	II	Lack of Assurance of Sterility	GenoGenix LLC
Jul 30, 2025	copper peptide	II	Lack of Assurance of Sterility	GenoGenix LLC
Jul 30, 2025	glutathione	II	Lack of Assurance of Sterility	GenoGenix LLC
Jul 24, 2015	glutathione	II	Lack of Assurance of Sterility; all sterile human compounded drugs within expiry	JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015	glutathione	II	Lack of Assurance of Sterility; all sterile human compounded drugs within expiry	JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 18, 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
Jul 18, 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
Jul 18, 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
Jul 18, 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
Jul 18, 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
Jul 18, 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
Jul 18, 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
Jan 2, 2019	glutathione	II	Lack of sterility assurance.	Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
Jan 2, 2019	glutathione	II	Lack of sterility assurance.	Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
Jan 19, 2018	glutathione	II	Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.	Flawless Beauty LLC
Jan 19, 2018	glutathione	II	Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.	Flawless Beauty LLC
Jan 19, 2018	glutathione	II	Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.	Flawless Beauty LLC
Jan 19, 2018	glutathione	II	Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.	Flawless Beauty LLC
Jan 19, 2018	glutathione	II	Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.	Flawless Beauty LLC
Jan 15, 2020	glutathione	II	Lack of Assurance of Sterility	Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Feb 10, 2017	nicotinamide	II	Lack of Assurance of Sterility: There are also CGMP Deviations.	Synergy Rx
Feb 10, 2017	nicotinamide	II	Lack of Assurance of Sterility: There are also CGMP Deviations.	Synergy Rx
Feb 10, 2017	nicotinamide	II	Lack of Assurance of Sterility: There are also CGMP Deviations.	Synergy Rx
Dec 22, 2022	nicotinamide	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
Dec 22, 2022	nicotinamide	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
Dec 22, 2022	glutathione	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
Dec 17, 2018	nicotinamide	II	Lack of sterility assurance.	Promise Pharmacy, LLC
Dec 17, 2018	glutathione	II	Lack of sterility assurance.	Promise Pharmacy, LLC
Dec 17, 2018	nicotinamide	II	Lack of sterility assurance.	Promise Pharmacy, LLC
Dec 17, 2018	nicotinamide	II	Lack of sterility assurance.	Promise Pharmacy, LLC
Dec 17, 2018	nicotinamide	II	Lack of sterility assurance.	Promise Pharmacy, LLC
Dec 12, 2014	glutathione	II	Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.	Right Value Drug Stores, Inc.
Aug 23, 2013	glutathione	II	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.	Wellness Pharmacy, Inc.
Aug 23, 2013	glutathione	II	Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.	Creative Compounds
Aug 21, 2018	glutathione	II	Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.	Auro Pharmacies, Inc.
Aug 15, 2017	glutathione	II	Lack of Assurance of Sterility.	Bella Pharmaceuticals, Inc.
Aug 13, 2021	glutathione	II	Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Aug 13, 2021	glutathione	II	Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Aug 12, 2019	glutathione	II	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Aug 12, 2019	glutathione	II	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Aug 12, 2019	glutathione	II	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Apr 8, 2019	glutathione	II	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Customceutical Compounding
Apr 29, 2014	glutathione	II	Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.	Flawless Beauty LLC
Apr 29, 2014	glutathione	II	Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.	Flawless Beauty LLC
Apr 29, 2014	glutathione	II	Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.	Flawless Beauty LLC
Apr 27, 2016	somatropin	II	Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step	Novo Nordisk Inc
Apr 18, 2017	glutathione	II	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.	Key Pharmacy and Compounding Center

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.