Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Mupirocin Ointment, USP 2%, 22 grams tube, Rx only, MFG: Teva Pharma USA, NDC... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bot... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | MethyLPREDNISolone Acetate Injectable Suspension, USP, 200 mg/5 mL (40 mg/mL)... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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.