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Browse Drug Recalls

213 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 213 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 213 FDA drug recalls.

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DateProductReasonClassFirm
Apr 13, 2022 Tropicamide Ophthalmic Solution, USP 1%, 3 mL bottle, Rx only, MFG: Sandoz P... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Distributed by: ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Loperamide Hydrochloride capsules, USP, 2 mg, 100-count bottle, Rx only, MFG:... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Biopsy and Aspiration Tray Bone Marrow Illinois 11GX4 (10/cs) Rx CRFPED Lidoc... 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 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 Bupivacaine HCl Injection, single dose vial, 0.5%, 30 mL/5 mg/mL, Rx only, Ma... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., N... 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 Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 E-Z-HD (Barium Sulfate for Oral Suspension), 98% w/w, 340 g bottle, 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 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 Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, ... 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 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 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 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 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 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 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 Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major P... 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 Cefazolin for injection USP, and Dextrose Injection, USP, 1G, 50 ML duplex co... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx on... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), pac... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5mL (80 mg/mL), ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: ... 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 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 Ciprofloxacin Ophthalmic Solution 0.3%, 10 mL bottle, Rx only, Manufactured b... 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 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 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 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 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 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

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.