Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 15, 2022 | Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC... | cGMP Deviations | Class II | Teva Pharmaceuticals USA Inc |
| Apr 15, 2022 | Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-c... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-co... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 13, 2022 | Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MF... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, M... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalatio... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 met... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | MethyLPREDNISolone Acetate Injectable Suspension, USP, 400 mg/10 mL (40 mg/mL... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x ... | 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 | 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 | Arzol (Silver Nitrate Applicator), (Silver Nitrate 75%, Potassium Nitrate 25%... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Geodon for injection (ziprasidone mesylate), 20 mg/mL, 1 mL single dose vial,... | 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 | 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 | Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Metoprolol tablets 50 mg, 100-count botte, Rx only, MFG: Sun Pharmaceuticals,... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Paracentesis/Thoracentises Tray (10/cs) Rx CRFPED, Lidocaine Hydrochloride US... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| 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 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit d... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Lidocaine Patch 5%, 30-count carton, Rx only, MFG: Qualitest Products, NDC 06... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Celestone Soluspan (betamethasone sodium phosphate and betametasone acetate i... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Lidocaine Patch 5%, 30-count box, Rx only, MFG: Teva Pharma USA, NDC 0591-352... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes, Rx only, MFG: Sandoz... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL, Rx only,... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Glucagen (glucagon) for injection, packaged in a 10-count box, (10 vials each... | 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 | Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL s... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Sumatriptan Injection, USP, 6mg/0.5 mL, packaged in a box of 5 x 0.5 mL singl... | 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 | Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Cefazolin for injection USP, and Dextrose Injection, USP, 2 g, 50 mL duplex c... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL, Rx only, ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Ph... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 met... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.3 mg, packaged in 2 ... | 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 | Olanzapine Orally Disintegrating Tablets, USP 10 mg, 30-count box unit dose t... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Intralipid (I.V. Fat emulsion), 20%, 100 mL bag, Rx only, MFG: Baxter Healthc... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Sumatriptan Succinate Tablets, 100 mg, 9 (1 x 9) Unit-of- use tablets box, Rx... | 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 |
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.