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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
Jan 16, 2026 UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syrin... Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrect... Class I McKesson
Aug 27, 2025 McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1),... CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... Class II DermaRite Industries, LLC
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
Jan 24, 2025 HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only... Failed Impurities/Degradation Specifications Class II SKY PACKAGING
Jan 24, 2025 HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactu... Failed Impurities/Degradation Specifications Class II SKY PACKAGING
Jan 17, 2025 Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL... cGMP Deviations: Product intended for quarantine was inadvertently distributed. Class II McKesson
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 12, 2024 CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1... CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was... Class II MCKESSON CORPORATION
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 13, 2023 Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL O... CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... Class II K.C. Pharmaceuticals, Inc
Jun 13, 2023 Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polye... CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... Class II K.C. Pharmaceuticals, Inc
Jul 15, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 ... CGMP Deviations Class II Vi-Jon, LLC
Jul 15, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 F... CGMP Deviations Class II Vi-Jon, LLC
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 21, 2022 Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expresse... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Dist... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufac... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by:... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx ... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
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

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.