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 |
|---|---|---|---|---|
| Jan 16, 2024 | Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flav... | CGMP Deviations: products may not conform to the labeled specifications. | Class II | Den-Mat Holdings, LLC |
| Jan 15, 2024 | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only,... | Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. | Class II | Amneal Pharmaceuticals of New York, LLC |
| Jan 12, 2024 | Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wi... | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... | Class I | Neptune Resources, LLC |
| Jan 12, 2024 | Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 7... | Subpotent Drug | Class II | IntegraDose Compounding Services LLC |
| Jan 12, 2024 | Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, ... | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... | Class I | Neptune Resources, LLC |
| Jan 12, 2024 | Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Di... | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... | Class I | Neptune Resources, LLC |
| Jan 12, 2024 | Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Markete... | Failed Dissolution Specifications | Class II | Golden State Medical Supply Inc. |
| Jan 11, 2024 | Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx... | Failed Impurities/Degradation Specification. | Class II | Amerisource Health Services LLC |
| Jan 11, 2024 | Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 u... | Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper speci... | Class II | Par Sterile Products LLC |
| Jan 10, 2024 | Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Parabe... | Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while t... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 10, 2024 | Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for I... | Lack of Sterility Assurance: Aseptic process simulation failure. | Class II | BE PHARMACEUTICALS AG |
| Jan 8, 2024 | Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactu... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 5, 2024 | Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lu... | Subpotent Drug and Failed Impurities/Degradation Specifications | Class II | Lupin Pharmaceuticals Inc. |
| Jan 5, 2024 | Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lup... | Subpotent Drug and Failed Impurities/Degradation Specifications | Class II | Lupin Pharmaceuticals Inc. |
| Jan 4, 2024 | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle,... | Labeling: Label Mix-up | Class I | Azurity Pharmaceuticals, Inc. |
| Jan 4, 2024 | Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill v... | Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 3, 2024 | Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured f... | Failed Impurities/Degradation Specifications | Class II | Lupin Pharmaceuticals Inc. |
| Jan 2, 2024 | Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's ... | Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets. | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 29, 2023 | buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bo... | Presence of Foreign Tablets/Capsules | Class II | Rising Pharma Holding, Inc. |
| Dec 29, 2023 | Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: St... | Failed Dissolution Specifications | Class II | Strides Pharma Inc. |
| Dec 29, 2023 | Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle... | Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an ... | Class II | Ascend Laboratories, LLC |
| Dec 28, 2023 | VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F320... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
| Dec 28, 2023 | PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
| Dec 28, 2023 | Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydro... | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... | Class II | Seaway Pharma Inc. |
| Dec 28, 2023 | Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump M... | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... | Class II | Seaway Pharma Inc. |
| Dec 28, 2023 | PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Ite... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
| Dec 28, 2023 | FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL)... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
| Dec 28, 2023 | VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F32... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
| Dec 28, 2023 | FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL)... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
| Dec 28, 2023 | DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, pack... | Lack of Sterility Assurance | Class II | Fresenius Medical Care Holdings, Inc. |
| Dec 28, 2023 | Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guai... | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... | Class II | Seaway Pharma Inc. |
| Dec 28, 2023 | Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydro... | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... | Class II | Seaway Pharma Inc. |
| Dec 26, 2023 | Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets,... | Failed dissolution specifications | Class II | Amneal Pharmaceuticals of New York, LLC |
| Dec 26, 2023 | Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose c... | Superpotent drug: Assay results were slightly above specification at the time zero point. | Class III | Amerisource Health Services LLC |
| Dec 26, 2023 | Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorph... | Microbial Contamination of Non-Sterile Products | Class I | Haleon US Holdings LLC |
| Dec 26, 2023 | Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramin... | Microbial Contamination of Non-Sterile Products | Class I | Haleon US Holdings LLC |
| Dec 21, 2023 | Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Class II | Pharma Nobis LLC |
| Dec 21, 2023 | Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxativ... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Class II | Pharma Nobis LLC |
| Dec 21, 2023 | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJE... | Presence of Particulate Matter; identified as glass | Class I | Pfizer Inc. |
| Dec 21, 2023 | Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop ... | Presence of particulate matter: glass | Class I | PFIZER |
| Dec 21, 2023 | CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Fla... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Class II | Pharma Nobis LLC |
| Dec 21, 2023 | Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABB... | Presence of Particulate Matter; identified as glass | Class I | Pfizer Inc. |
| Dec 21, 2023 | Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Class II | Pharma Nobis LLC |
| Dec 21, 2023 | 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, ... | Presence of Particulate Matter; identified as glass | Class I | Pfizer Inc. |
| Dec 21, 2023 | Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Fre... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Class II | Pharma Nobis LLC |
| Dec 21, 2023 | Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can... | Chemical Contamination: presence of benzene | Class I | Insight Pharmaceuticals LLC, a Prestige Consume... |
| Dec 20, 2023 | Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 coun... | CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit. | Class II | Lupin Pharmaceuticals Inc. |
| Dec 15, 2023 | Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr... | Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tac... | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 13, 2023 | Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-C... | CGMP Deviations: Stability data does not support expiry date. | Class II | Private Label Partners, Inc. |
| Dec 12, 2023 | ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg.... | Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification | Class III | GlaxoSmithKline LLC |
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.