Browse Drug Recalls
157 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 157 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 157 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 25, 2025 | Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Sin... | Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 25, 2025 | Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) an... | Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 21, 2025 | PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, M... | CGMP Deviations; potential temperature excursions due to transit delays | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 21, 2025 | BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-10... | CGMP Deviations; potential temperature excursions due to transit delays | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 21, 2025 | EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use O... | CGMP Deviations; potential temperature excursions due to transit delays | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Sep 11, 2024 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bot... | Temperature abuse: Products exposed to improper temperature above drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Sep 11, 2024 | Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Singl... | cGMP Deviations: Temperature excursion | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Feb 7, 2024 | Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MF... | cGMP Deviations: Products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Feb 7, 2024 | Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vi... | cGMP Deviations: Products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Feb 7, 2024 | Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Sy... | cGMP Deviations: Products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manuf... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Ba... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per ... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restor... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propyle... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories pe... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Red... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B su... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alco... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, M... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporar... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhal... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL... | cGMP deviations: Temperature abuse | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, 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 |
| 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 | 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 | Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz P... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 40 mg/mL,... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | MethyLPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a... | 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 | 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 | 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 | 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 | Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25... | 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.