Browse Drug Recalls
1,122 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,122 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 1,122 FDA drug recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 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 | 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 | 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 | 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 1.5g 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 | 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 | 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 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 | 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 | 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 | Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can... | Chemical Contamination: presence of benzene | Class I | Insight Pharmaceuticals LLC, a Prestige Consume... |
| 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 | 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 | 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 | Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop ... | Presence of particulate matter: glass | Class I | PFIZER |
| 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 | 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 | 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 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 |
| Dec 11, 2023 | NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx O... | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Class II | Fagron, Inc |
| Dec 11, 2023 | NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Onl... | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Class II | Fagron, Inc |
| Dec 11, 2023 | Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Ma... | CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. | Class II | Legacy Pharmaceutical Packaging LLC |
| Dec 11, 2023 | NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx O... | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Class II | Fagron, Inc |
| Dec 11, 2023 | NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only... | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Class II | Fagron, Inc |
| Dec 8, 2023 | Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufa... | Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylid... | Class III | Azurity Pharmaceuticals, Inc. |
| Dec 4, 2023 | Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distribute... | Failed Impurities/Degradation Specifications | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Nov 29, 2023 | ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Inje... | STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag con... | Class II | STAQ Pharma, Inc. |
| Nov 29, 2023 | Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed... | Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutic... | Class I | Meta Herbal |
| Nov 22, 2023 | B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxin... | Presence of Particulate Matter. | Class II | AnazaoHealth Corporation |
| Nov 22, 2023 | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL b... | Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals | Class I | Novartis Pharmaceuticals Corporation |
| Nov 22, 2023 | TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET... | Chemical Contamination; presence of benzene. | Class I | Insight Pharmaceuticals Corporation |
| Nov 22, 2023 | ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL... | Lack of assurance of sterility. | Class II | Wells Pharma of Houston LLC |
| Nov 22, 2023 | buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets... | Failed Dissolution Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Nov 22, 2023 | Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber... | Presence of Particulate Matter. | Class II | AnazaoHealth Corporation |
| Nov 22, 2023 | Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for... | Failed Dissolution Specifications | Class II | Lupin Pharmaceuticals Inc. |
| Nov 20, 2023 | Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured ... | Failed Dissolution Specifications | Class III | Siegfried Barbera, SL |
| Nov 17, 2023 | Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx O... | Defective Container: powder may leak out of the pouch | Class I | InvaGen 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.