Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 4... | Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine. | Class I | Qikmoov LLC |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzon... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| 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 Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | Chemical Contamination: presence of benzene | Class I | 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 | 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 Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, 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 COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50... | 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 Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, 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 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 ... | Chemical Contamination: presence of benzene | Class I | 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 Semorelin/Ipamorelin 3 mg For subcutaneous or intramus... | Lack of Assurance of Sterility | Class II | Innoveix Pharmaceuticals 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 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 7, 2021 | Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 5... | Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the ... | Class III | LNK International, Inc. |
| Jul 2, 2021 | Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By... | Temperature abuse: the firm received customer complaints of unusual grittiness in the product. | Class I | KVK-Tech, 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 | MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50... | Lack of processing controls | Class II | Promise Pharmacy, 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 | 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 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 23, 2021 | LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vi... | FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramos... | Class III | Partner Therapeutics Inc |
| Jun 22, 2021 | Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(N... | Failed Impurities/Degradation Specifications | Class III | Teligent Pharma, Inc. |
| 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 22, 2021 | Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., ... | Failed Impurities/Degradation Specifications | Class III | Teligent Pharma, Inc. |
| Jun 22, 2021 | Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured... | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... | Class I | Ardil Comercial S.R.L. |
| Jun 21, 2021 | Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitiz... | Hand sanitizer packaged in bottles that resemble beverage containers. | Class I | Prairie Wolf Spirits |
| Jun 18, 2021 | Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceutical... | Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. ... | Class I | Teva Pharmaceuticals USA |
| Jun 18, 2021 | B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutri... | Superpotent | Class III | Grato Holdings, 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 9, 2021 | Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured... | Failed Impurities Specification: Out of specification when measuring the impurity degradant D level. | Class III | AVKARE Inc. |
| Jun 8, 2021 | Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded ... | Labeling: Incorrect Exp. Date: Incorrect BUD. | Class III | Prisma Health Outsourcing Facility |
| Jun 8, 2021 | Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufacture... | Failed Impurities/Degradation Specifications | Class III | Bausch Health Companies, 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.