Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 13, 2022 | Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Epidural Tray, Nerve Block Single shot, Rx only, # 182207, MFG: Avanos Medica... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Dihydroergotamine Mesylate, Injection, USP, 1mg/mL, packaged in box of 5 x 1 ... | 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 | Prazosin Hydrochloride Capsules, USP, 1 mg, 100-count bottle, Rx only, MFG: M... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | BSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle, Rx o... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Olanzapine single dose vial Lyophilized, 10 mg, Rx only, MFG: Auromedics Phar... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC... | 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 | Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3m... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pha... | 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 | 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 | Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1mg/mL), 30 mL multiple d... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | MethyLPREDNISolone Acetate Injectable Suspension, USP, 200mg/5mL (40 mg/mL), ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Xylocaine - MPF (lidocaine HCl and epinephrine injection, USP), 1%, 300 mg/30... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Lidocaine Patch, 5%, 30-count box, Rx only, Manufacturer: Rhodes Pharmaceutic... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | MethyLPREDNISolone Acetate Injectable Suspension USP, 80 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 with Dose Indicator, 90 mcg, 200 met... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Diprivan (Propofol) Emulsion, 100 mg/mL, 10mL vial, Rx only, MFG: App Pharma... | 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 | 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 | 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 | 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 | 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 | Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2... | 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 | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per... | 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 | 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 | 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 | 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 | MIOSTAT (Carbachol Intraocular Solution, USP) 0.01%, 1.5 mL, Rx only, MFG: Al... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-fiv... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, R... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Recothrom Thrombin Topical (Recombinant), 5,000 units, packaged in a box cont... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG:... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dos... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered i... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Diprivan (Propofol) Emulsion, 200 mg per 20 mL (10mg/mL), 20 mL vial, Rx only... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pha... | 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 | Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Man... | 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 | Betamethasone Dipropionate Cream USP, 0.05%, 45 grams tube, Rx only, MFG: San... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only... | 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 |
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.