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 |
|---|---|---|---|---|
| Jan 18, 2024 | Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, D... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distri... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 17, 2024 | Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Pack... | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouc... | Class II | Henry Schein Inc. and Glove Club HSI Gloves Inc. |
| Jan 16, 2024 | Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of... | Failed Impurities/Degradation Specification: Out of specification for organic impurities | Class II | Ascend Laboratories, LLC |
| Jan 16, 2024 | OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcoh... | CGMP Deviations: products may not conform to the labeled specifications. | Class II | Den-Mat Holdings, LLC |
| 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 | Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Markete... | Failed Dissolution Specifications | Class II | Golden State Medical Supply Inc. |
| 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 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 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 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 | 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 | 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 | 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 | 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 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 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 | 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 | 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 | 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 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 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 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 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 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 22, 2023 | B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxin... | Presence of Particulate Matter. | Class II | AnazaoHealth 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 | Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for... | Failed Dissolution Specifications | Class II | Lupin Pharmaceuticals 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 |
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.