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 | Xylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count b... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | GlucaGen (glucagon) for injection, 1 mg per vial, single dose kit, 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 | 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 | 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 | 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 | Epinephrine, ABJT 0.1 mg/mL, 10 mL, 20GX1.5 (10 pack), Rx only, MFG: Pfizer,... | 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 13, 2022 | Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Maj... | 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 | 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 | Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), pac... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Thrombin JMI, Vial 5,000IU 2/diluent, kit, Rx only, MFG: Pfizer NDC 60793-2... | 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 | 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 | 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 | Intralipid (I.V. Fat emulsion), 20%, 250 mL bag, Rx only, MFG: Baxter Healthc... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG:... | 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 | Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manu... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: ... | 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.