Browse Drug Recalls

1,122 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,122 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 1,122 FDA drug recalls in 2023.

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Date	Product	Reason	Class	Firm
Feb 24, 2023	Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83...	Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.	Class I	Global Pharma Healthcare Private Limited
Feb 24, 2023	Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) p...	CGMP DEVIATIONS	Class II	Ecometics, Inc.
Feb 24, 2023	Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentratio...	Subpotent Drug	Class III	SCA Pharmaceuticals
Feb 24, 2023	Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in ...	CGMP DEVIATIONS	Class II	Ecometics, Inc.
Feb 23, 2023	Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron...	CGMP Deviations: Potential product carryover.	Class II	Nephron Sc Inc
Feb 23, 2023	NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% A...	CGMP Deviations: Raw material recalled by repackager, due to discoloration.	Class II	Nutraceutical Corporation
Feb 23, 2023	NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, ...	CGMP Deviations: Raw material recalled by repackager, due to discoloration.	Class II	Nutraceutical Corporation
Feb 23, 2023	NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), ...	CGMP Deviations: Raw material recalled by repackager, due to discoloration.	Class II	Nutraceutical Corporation
Feb 23, 2023	Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx ...	Packaging defect: observed packaging defect, blister packaging inadequately sealed.	Class II	The Harvard Drug Group
Feb 23, 2023	NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid D...	CGMP Deviations: Raw material recalled by repackager, due to discoloration.	Class II	Nutraceutical Corporation
Feb 23, 2023	Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride op...	Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained fo...	Class II	Teva Pharmaceuticals USA Inc
Feb 22, 2023	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 m...	Lack of Assurance of Sterility	Class II	Nephron Sterile Compounding Center LLC
Feb 22, 2023	Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose ...	Lack of Assurance of Sterility	Class II	Nephron Sterile Compounding Center LLC
Feb 22, 2023	Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 m...	Lack of Assurance of Sterility	Class II	Nephron Sterile Compounding Center LLC
Feb 22, 2023	Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R...	CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da...	Class II	Teva Pharmaceuticals USA Inc
Feb 22, 2023	Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125...	Lack of Assurance of Sterility	Class II	Nephron Sterile Compounding Center LLC
Feb 22, 2023	Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose...	Lack of Assurance of Sterility	Class II	Nephron Sterile Compounding Center LLC
Feb 22, 2023	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL...	Lack of Assurance of Sterility	Class II	Nephron Sterile Compounding Center LLC
Feb 22, 2023	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL...	Lack of Assurance of Sterility	Class II	Nephron Sterile Compounding Center LLC
Feb 22, 2023	Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose...	Lack of Assurance of Sterility	Class II	Nephron Sterile Compounding Center LLC
Feb 21, 2023	Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV ...	CGMP DEVIATIONS	Class II	Denver Solutions, LLC DBA Leiters Health
Feb 21, 2023	Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiter...	CGMP DEVIATIONS	Class II	Denver Solutions, LLC DBA Leiters Health
Feb 21, 2023	Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 f...	Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Stan...	Class III	Padagis US LLC
Feb 21, 2023	Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters...	CGMP DEVIATIONS	Class II	Denver Solutions, LLC DBA Leiters Health
Feb 21, 2023	Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV B...	CGMP DEVIATIONS	Class II	Denver Solutions, LLC DBA Leiters Health
Feb 17, 2023	Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured...	Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800...	Class III	Sciegen Pharmaceuticals Inc
Feb 17, 2023	DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Ph...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Akron Pharma, Inc.
Feb 15, 2023	Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by:...	Failed Impurities/Degradation Specifications	Class II	RISING PHARMACEUTICALS
Feb 15, 2023	Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One...	Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro...	Class III	AVEVA Drug Delivery Systems, Inc.
Feb 15, 2023	Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One...	Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro...	Class III	AVEVA Drug Delivery Systems, Inc.
Feb 15, 2023	Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL...	cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.	Class II	Azurity Pharmaceuticals, Inc.
Feb 14, 2023	Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-S...	Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and ace...	Class I	Nanomaterials Discovery Corporation
Feb 14, 2023	Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31...	Non-Sterility	Class I	Pharmedica USA, LLC
Feb 14, 2023	Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles,...	CGMP Deviations	Class II	Pharmedica USA, LLC
Feb 13, 2023	PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-c...	Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar...	Class I	Volt Candy Wholesale Club
Feb 10, 2023	0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B....	Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ...	Class II	B. Braun Medical Inc.
Feb 10, 2023	0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B...	Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ...	Class II	B. Braun Medical Inc.
Feb 9, 2023	allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-...	Failed Impurities/Degradation Specifications	Class II	L. Perrigo Company
Feb 9, 2023	Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30...	Failed Impurities/Degradation Specifications	Class II	L. Perrigo Company
Feb 9, 2023	allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-c...	Failed Impurities/Degradation Specifications	Class II	L. Perrigo Company
Feb 9, 2023	Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive ...	cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.	Class II	HTO Nevada, Inc.
Feb 9, 2023	allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-...	Failed Impurities/Degradation Specifications	Class II	L. Perrigo Company
Feb 9, 2023	Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons,...	Failed Impurities/Degradation Specifications	Class II	L. Perrigo Company
Feb 9, 2023	Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by...	Failed Impurities/Degradation Specifications	Class II	L. Perrigo Company
Feb 9, 2023	Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons,...	Failed Impurities/Degradation Specifications	Class II	L. Perrigo Company
Feb 9, 2023	New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain s...	cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.	Class II	HTO Nevada, Inc.
Feb 9, 2023	Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (...	Failed Impurities/Degradation Specifications	Class II	L. Perrigo Company
Feb 9, 2023	Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count c...	Failed Impurities/Degradation Specifications	Class II	L. Perrigo Company
Feb 9, 2023	Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count ...	Failed Impurities/Degradation Specifications	Class II	L. Perrigo Company
Feb 9, 2023	Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-co...	Failed Impurities/Degradation Specifications	Class II	L. Perrigo Company

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.