Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Jul 14, 2021 Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone ... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzo... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRU... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone ... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate ... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50... cGMP Deviations Class II Johnson & Johnson Consumer, Inc.
Jul 12, 2021 QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, M... Subpotent Class II NATIVE PROMOTIONS, INC
Jul 9, 2021 Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injec... Lack of Assurance of Sterility Class II Innoveix Pharmaceuticals Inc
Jul 9, 2021 Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramus... Lack of Assurance of Sterility Class II Innoveix Pharmaceuticals Inc
Jul 7, 2021 Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, ... Presence of Foreign Substance- Potential of metal contamination. Class II Aurobindo Pharma USA Inc.
Jul 2, 2021 NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 cou... Failed Dissolution Specification: Out of specification for dissolution during routine stability t... Class II The Harvard Drug Group
Jun 30, 2021 Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-ste... CGMP Deviations: Does not meet monograph for denaturant. Class II Cascade Kelly Holdings LLC
Jun 30, 2021 Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-ste... CGMP Deviations: Does not meet monograph for denaturant. Class II Cascade Kelly Holdings LLC
Jun 30, 2021 MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50... Lack of processing controls Class II Promise Pharmacy, LLC
Jun 29, 2021 Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, R... cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cak... Class II Eli Lilly & Company
Jun 25, 2021 Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Inje... Low out of specification results for epinephrine assay. Class II Fresenius Kabi USA LLC
Jun 22, 2021 QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, M... Subpotent Class II HOYU(US) LOGISTICS INC
Jun 16, 2021 Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottl... cGMP deviations: Discolored acetaminophen Class II Spirit Pharmaceuticals
Jun 10, 2021 Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured... CGMP Deviations Class II CIPLA
Jun 9, 2021 Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For... Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content we... Class II Genentech Inc
Jun 9, 2021 Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pf... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Jun 9, 2021 QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzh... Subpotent Class II World Source Llc
Jun 9, 2021 Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfiz... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acc... Class II Pfizer Inc.
Jun 9, 2021 Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acc... Class II Pfizer Inc.
Jun 1, 2021 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx... CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... Class II VIONA PHARMACEUTICALS INC
May 21, 2021 DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx ... Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper. Class II Hill Dermaceuticals, Inc.
May 20, 2021 Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1... Defective Delivery System: The number of customer complaints for ripping patches and tight releas... Class II Noven Pharmaceuticals Inc
May 20, 2021 Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1... Defective Delivery System: The number of customer complaints for ripping patches and tight releas... Class II Noven Pharmaceuticals Inc
May 14, 2021 Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-... Presence of Foreign Substance: Foreign particles observed during routine stability testing. Class II Teligent Pharma, Inc.
May 13, 2021 Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium n... Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluori... Class II Accupac, Inc.
May 12, 2021 MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufa... Class II Global Sanitizers LLC
May 12, 2021 MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufa... Class II Global Sanitizers LLC
May 12, 2021 MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alco... CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufac... Class II Global Sanitizers LLC
May 12, 2021 MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufa... Class II Global Sanitizers LLC
May 11, 2021 Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beau... Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ing... Class II DASH XCLUSIVE
May 11, 2021 ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002... CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... Class II DIBAR NUTRICIONAL S DE RL DE CV
May 11, 2021 ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by... CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... Class II DIBAR NUTRICIONAL S DE RL DE CV
May 11, 2021 DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.... CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... Class II DIBAR NUTRICIONAL S DE RL DE CV
May 5, 2021 BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manuf... Presence of Foreign Tablets/Capsules Class II Oxford Pharmaceuticals, LLC
May 4, 2021 Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx... Subpotent Drug Class II Boehringer Ingelheim Pharmaceuticals, 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.