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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.