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.

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DateProductReasonClassFirm
Oct 26, 2021 Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL O... 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 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 No Drip Nasal Decongestant, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bott... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (5... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Deconges... 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 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 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), 4 FL O... 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 Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 0.05% Na... 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 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 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 artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), ... CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as t... Class II VIRGIN SCENT INC
Oct 26, 2021 Severe Congestion No Drip Nasal Spray 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 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 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 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 Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (5... 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 Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5... 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 Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL O... 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 25, 2021 Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Nor... Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the pro... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 25, 2021 Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Nort... Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the pro... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 25, 2021 Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: U... Discoloration Class III UNICHEM PHARMACEUTICALS USA INC
Oct 22, 2021 Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Ph... Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 20, 2021 Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... Failed Stability Specifications: Out-of-specification results observed in a water loss test that ... Class III Lupin Pharmaceuticals Inc.
Oct 19, 2021 Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx onl... Presence of Particulate Matter: Identified as Glass Particles Class I MERCK SHARP & DOHME CORP
Oct 19, 2021 Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bot... Defective Container Class II Teligent Pharma, Inc.
Oct 19, 2021 Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bot... Defective Container Class II Teligent Pharma, Inc.
Oct 18, 2021 Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Uni... Out-of-specification test results obtained in Organic Impurities test during analysis of controll... Class III MACLEODS PHARMA USA, INC
Oct 18, 2021 Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Un... Out-of-specification test results obtained in Organic Impurities test during analysis of controll... Class III MACLEODS PHARMA USA, INC
Oct 18, 2021 Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2... Out-of-specification test results obtained in Organic Impurities test during analysis of controll... Class III MACLEODS PHARMA USA, INC
Oct 14, 2021 Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, M... Failed Excipient Specification; product manufactured using an excipient found to be OOS for condu... Class II Golden State Medical Supply Inc.
Oct 14, 2021 Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets,... Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured us... Class II Golden State Medical Supply Inc.
Oct 13, 2021 PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 ... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) t... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 6... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 12, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 30 INJ INJECTABLE, Rx only, Talo... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy

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.