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 |
|---|---|---|---|---|
| Apr 20, 2023 | G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric... | Product mix-up: incorrect product was found inside the G-Supress DX product carton. | Class I | Novis PR, LLC dba Kramer Novis |
| Apr 19, 2023 | Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Ster... | Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. | Class II | Sun Pharmaceutical Industries Ltd. |
| Apr 19, 2023 | Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Sol... | Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the label... | Class II | Seatex LLC |
| Apr 13, 2023 | Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / ... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder ... | Lack of assurance of sterility. | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Apr 11, 2023 | Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial,... | Lack of Assurance of Sterility: Malformed crimped collar seal | Class II | Sanofi-Aventis U.S. LLC |
| Apr 10, 2023 | Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose ... | Subpotent Drug: Out of specification results for low potency was obtained. | Class III | SCA Pharmaceuticals |
| Apr 7, 2023 | Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For... | CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inven... | Class II | Methapharm Inc |
| Apr 6, 2023 | Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India... | CGMP deviations. | Class II | PD-Rx Pharmaceuticals, Inc. |
| Apr 6, 2023 | Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limite... | CGMP deviations. | Class II | PD-Rx Pharmaceuticals, Inc. |
| Apr 6, 2023 | Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By... | CGMP deviations. | Class II | PD-Rx Pharmaceuticals, Inc. |
| Apr 6, 2023 | Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 m... | CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation. | Class II | Pharma Nobis LLC |
| Apr 6, 2023 | Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India ... | CGMP deviations. | Class II | PD-Rx Pharmaceuticals, Inc. |
| Apr 6, 2023 | Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India ... | CGMP deviations. | Class II | PD-Rx Pharmaceuticals, Inc. |
| Mar 31, 2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged ... | CGMP deviation: product outside labeled storage temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Mar 31, 2023 | Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever R... | CGMP deviation: product outside labeled storage temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Mar 31, 2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count ... | CGMP deviation: product outside labeled storage temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Mar 31, 2023 | Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAI... | CGMP deviation: product outside labeled storage temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Mar 29, 2023 | Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multipl... | Sub-potent drug: assay test result below specifications at 9-month timepoint. | Class III | Accord Healthcare, Inc. |
| Mar 29, 2023 | Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-d... | Failed Impurities/Degradation Specifications: Above the specification limits yielded for related ... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 27, 2023 | Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. | Class III | Pine Pharmaceuticals, LLC |
| Mar 27, 2023 | Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solutio... | Chemical Contamination: FDA testing found Presence of methanol | Class I | Jarman's Midwest Cleaning Systems, Inc. |
| Mar 27, 2023 | SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STER... | Chemical Contamination: FDA testing found Presence of methanol | Class I | Jarman's Midwest Cleaning Systems, Inc. |
| Mar 27, 2023 | Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-... | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 27, 2023 | Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-steril... | CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of met... | Class II | Jarman's Midwest Cleaning Systems, Inc. |
| Mar 27, 2023 | Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 3... | Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. | Class III | Teva Pharmaceuticals USA Inc |
| Mar 27, 2023 | Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-75... | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 27, 2023 | Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharma... | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (ND... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactu... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: ... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accor... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC ... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufacture... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: ... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Acc... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Acco... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accor... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 22, 2023 | Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distribute... | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... | Class II | Direct Rx |
| Mar 22, 2023 | Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed ... | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... | Class II | Direct Rx |
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.