Browse Drug Recalls

930 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 930 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 930 FDA drug recalls in 2020.

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Date	Product	Reason	Class	Firm
Mar 16, 2020	ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL...	Firm is recalling 46 lots of various products because of a lack of sterility assurance.	Class II	PharMEDium Services, LLC
Mar 16, 2020	Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement ...	Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tada...	Class I	Y-O Management LLC, dba Natural Remedy Store
Mar 16, 2020	Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F005...	Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor...	Class II	Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020	fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare B...	Firm is recalling 46 lots of various products because of a lack of sterility assurance.	Class II	PharMEDium Services, LLC
Mar 16, 2020	nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP...	Firm is recalling 46 lots of various products because of a lack of sterility assurance.	Class II	PharMEDium Services, LLC
Mar 16, 2020	rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, ...	Firm is recalling 46 lots of various products because of a lack of sterility assurance.	Class II	PharMEDium Services, LLC
Mar 16, 2020	ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 ...	Firm is recalling 46 lots of various products because of a lack of sterility assurance.	Class II	PharMEDium Services, LLC
Mar 16, 2020	fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe,...	Firm is recalling 46 lots of various products because of a lack of sterility assurance.	Class II	PharMEDium Services, LLC
Mar 16, 2020	Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tam...	Lack of Assurance of Sterility	Class II	The Medicine Shoppe Pharmacy
Mar 16, 2020	HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per...	Firm is recalling 46 lots of various products because of a lack of sterility assurance.	Class II	PharMEDium Services, LLC
Mar 16, 2020	fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, Fo...	Firm is recalling 46 lots of various products because of a lack of sterility assurance.	Class II	PharMEDium Services, LLC
Mar 16, 2020	fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,...	Firm is recalling 46 lots of various products because of a lack of sterility assurance.	Class II	PharMEDium Services, LLC
Mar 16, 2020	Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with...	Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor...	Class II	Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020	Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. A...	Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor...	Class II	Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020	ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride ...	Firm is recalling 46 lots of various products because of a lack of sterility assurance.	Class II	PharMEDium Services, LLC
Mar 16, 2020	ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL B...	Firm is recalling 46 lots of various products because of a lack of sterility assurance.	Class II	PharMEDium Services, LLC
Mar 16, 2020	succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, F...	Firm is recalling 46 lots of various products because of a lack of sterility assurance.	Class II	PharMEDium Services, LLC
Mar 16, 2020	Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bot...	Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor...	Class II	Glaxosmithkline Consumer Healthcare Holdings
Mar 13, 2020	*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Ph...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Medical Center Pharmacy, Inc.
Mar 13, 2020	C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Me...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Medical Center Pharmacy, Inc.
Mar 13, 2020	C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Medical Center Pharmacy, Inc.
Mar 13, 2020	Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by:...	CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Prac...	Class II	Sun Pharmaceutical Industries, Inc.
Mar 13, 2020	*Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pha...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Medical Center Pharmacy, Inc.
Mar 13, 2020	C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharma...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Medical Center Pharmacy, Inc.
Mar 13, 2020	Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by:...	CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Prac...	Class II	Sun Pharmaceutical Industries, Inc.
Mar 11, 2020	Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx ...	CGMP Deviations: Presence of dark brown discoloration on edges of tablets	Class II	Jubilant Cadista Pharmaceuticals, Inc.
Mar 10, 2020	Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with c...	Subpotent Drug	Class II	Matthew 7:25 Inc dba Thrive Pharmacy
Mar 10, 2020	Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with...	Subpotent Drug	Class II	Matthew 7:25 Inc dba Thrive Pharmacy
Mar 10, 2020	Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with...	Subpotent Drug	Class II	Matthew 7:25 Inc dba Thrive Pharmacy
Mar 9, 2020	Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactu...	Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of At...	Class II	Sun Pharmaceutical Industries, Inc.
Mar 9, 2020	Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and e...	Failed Content Uniformity Specifications: Out Of Specification test results observed for content ...	Class III	Lupin Pharmaceuticals Inc.
Mar 9, 2020	Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.0...	Failed Content Uniformity Specifications: Out Of Specification test results observed for content ...	Class II	Lupin Pharmaceuticals Inc.
Mar 9, 2020	Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharma...	Presence of particulate matter. presence of metal particles.	Class II	Mylan Pharmaceuticals Inc.
Mar 6, 2020	Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-...	Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement...	Class II	H J Harkins Company Inc dba Pharma Pac
Mar 6, 2020	Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, ...	CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/...	Class II	Nostrum Laboratories Inc
Mar 5, 2020	Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled ...	CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-market...	Class II	Teva Pharmaceuticals USA
Mar 5, 2020	Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: ...	CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.	Class II	Fresenius Medical Care Holdings, Inc.
Mar 4, 2020	PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par...	Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Pre...	Class III	Par Pharmaceutical Inc.
Mar 3, 2020	PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g...	Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for ...	Class II	Yusef Manufacturing Laboratories, LLC
Mar 2, 2020	Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 ...	Defective Delivery System: Out of specification for mechanical peel and shear.	Class II	Noven Therapeutics, LLC
Mar 2, 2020	Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 ...	Defective Delivery System: Out of specification for mechanical peel and shear.	Class II	Noven Therapeutics, LLC
Mar 2, 2020	Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 ...	Defective Delivery System: Out of specification for mechanical peel and shear.	Class II	Noven Therapeutics, LLC
Mar 2, 2020	Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayn...	Product Mix-Up: A foreign tablet was found in bottle.	Class II	Mayne Pharma Inc
Mar 2, 2020	Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 ...	Defective Delivery System: Out of specification for mechanical peel and shear.	Class II	Noven Therapeutics, LLC
Feb 28, 2020	Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, ...	cGMP Deviation	Class II	Sunstar Guangzhou Ltd.
Feb 27, 2020	Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dos...	Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q...	Class III	The Harvard Drug Group
Feb 27, 2020	Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit do...	Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q...	Class III	The Harvard Drug Group
Feb 27, 2020	Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit do...	Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q...	Class III	The Harvard Drug Group
Feb 27, 2020	Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit do...	Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q...	Class III	The Harvard Drug Group
Feb 27, 2020	Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distri...	Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The...	Class II	Pfizer Inc.

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.