Browse Drug Recalls

1,152 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,152 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 1,152 FDA drug recalls in 2021.

Date	Product	Reason	Class	Firm
Nov 12, 2021	Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), R...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Nov 12, 2021	Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), R...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Nov 12, 2021	Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Nov 12, 2021	Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Nov 12, 2021	PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Nov 12, 2021	Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Nov 12, 2021	Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin...	Failed dissolution specifications	Class III	Dr. Reddy's Laboratories, Inc.
Nov 12, 2021	Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin...	Failed dissolution specifications	Class III	Dr. Reddy's Laboratories, Inc.
Nov 12, 2021	NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Inje...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Nov 12, 2021	NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Inj...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Nov 12, 2021	12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine H...	Failed dissolution specifications	Class III	Dr. Reddy's Laboratories, Inc.
Nov 12, 2021	NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, R...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Nov 12, 2021	MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg p...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Nov 9, 2021	Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use,...	Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during ...	Class II	PAR Sterile Products LLC
Nov 8, 2021	Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR...	Superpotent Drug	Class II	TOLMAR, Inc.
Nov 8, 2021	Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, ND...	Defective Container: Customer complaints for leaking bottles and dispensing issues.	Class II	Medline Industries Inc
Nov 4, 2021	Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bot...	Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.	Class II	Amneal Pharmaceuticals of New York, LLC
Nov 4, 2021	Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bott...	Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.	Class II	Amneal Pharmaceuticals of New York, LLC
Nov 3, 2021	Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alke...	Failed Impurities/Degradation Specifications	Class II	Ascend Laboratories LLC
Nov 1, 2021	Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Ind...	cGMP Deviations: Product manufactured with contaminated raw ingredient.	Class II	Precision Dose Inc.
Nov 1, 2021	Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup...	cGMP Deviations: Product manufactured with contaminated raw ingredient.	Class II	Precision Dose Inc.
Oct 28, 2021	Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, ...	Failed Impurities/Degradation Specifications	Class III	Teva Pharmaceuticals USA
Oct 28, 2021	VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intraveno...	Crystallization: Product appears to be turbid.	Class II	Apollo Care
Oct 27, 2021	Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx...	Labelling: Incorrect Exp. Date	Class II	Teva Pharmaceuticals USA
Oct 26, 2021	Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo ...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), ...	Chemical Contamination: presence of benzene, acetaldehyde, and acetal.	Class I	VIRGIN SCENT INC
Oct 26, 2021	artnaturals Hand Sanitizer	CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as t...	Class II	VIRGIN SCENT INC
Oct 26, 2021	Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) p...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 ...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 ...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ ...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL ...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 ...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 ...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	No Drip Nasal Mist, Oxymetazoline HCl 0.05% Nasal decongestant, 1 FL Oz (30 m...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongest...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ ...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ ...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongest...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% ...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC
Oct 26, 2021	Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 ...	CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th...	Class II	Perrigo Company PLC

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.