Browse Drug Recalls
18,008 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18,008 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 18,008 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 13, 2022 | MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL),... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | MethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each bl... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG:... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic so... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial, 10-count box, Rx only... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: San... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sando... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), package... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distribut... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Verapamil HCL, ampule, 2.5 mg/ML 2ML (5/pack), Rx only, MFG: Pfizer, NDC 0409... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Ma... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 m... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmac... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset T... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Medroxyprogesterone acetate injectable suspension, 150 mg/mL, 1 mL single dos... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Ph... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Diphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL vials... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Aprepitant Capsule, USP, 40 mg, 1 capsule per unit dose package, Rx only, MFG... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only,... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 12, 2022 | Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutan... | Subpotent Drug: Out of specification for assay. | Class III | American Health Packaging |
| Apr 12, 2022 | Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), pac... | Labeling: Missing label on the vial | Class I | Mylan Pharmaceuticals Inc |
| Apr 12, 2022 | Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, I... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II | Preferred Pharmaceuticals, Inc. |
| Apr 11, 2022 | Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets ... | CGMP deviations: tablets cracking | Class II | Torrent Pharma Inc |
| Apr 7, 2022 | Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manuf... | Failed Impurities/Degradation Specifications: High out of specification results obtained for rela... | Class II | Mylan Pharmaceuticals Inc |
| Apr 6, 2022 | Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1)... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II | RemedyRepack Inc. |
| Apr 5, 2022 | LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenv... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 5, 2022 | Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL ... | Subpotent Drug: Out of Specification results for Assay | Class III | Aurobindo Pharma USA Inc. |
| Apr 5, 2022 | Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 5, 2022 | BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Green... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 5, 2022 | Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 5, 2022 | Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio ... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 5, 2022 | Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pe... | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage ... | Class II | Cardinal Health Inc. |
| Apr 5, 2022 | ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, F... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 5, 2022 | Kill 'Dat Sanitizing Products Hand Sanitizer, 1 gallon (128 fl. oz.) 80% Alco... | CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits. | Class II | Lula Holdings L.L.C. |
| Apr 5, 2022 | PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only,... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 5, 2022 | Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Pr... | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage ... | Class I | Cardinal Health Inc. |
| Apr 5, 2022 | Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose P... | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage ... | Class II | Cardinal Health Inc. |
| Apr 4, 2022 | QM-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL . A... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile ... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | T-106, Papaverine 30 mg/mL . Phentolamine 1 mg/mL . Alprostadil 25 mcg/mL, Pa... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 ... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, ... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atro... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmace... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
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.