Browse Drug Recalls
420 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 420 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 420 FDA drug recalls in VA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 26, 2026 | Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured ... | Presence of Foreign Tablets/Capsules | Class II | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Jun 24, 2025 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100... | Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the ... | Class II | Granules Pharmaceuticals Inc. |
| 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 |
| Dec 30, 2024 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bot... | Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottl... | Class II | Granules Pharmaceuticals Inc. |
| Dec 18, 2024 | Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granu... | Failed Dissolution Specifications: Out of specification observed during the accelerated stability... | Class II | Granules Pharmaceuticals Inc. |
| 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 |
| Jul 31, 2024 | Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by:... | Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabap... | Class II | Granules Pharmaceuticals Inc. |
| Jul 18, 2024 | Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid ... | Label mix-up: Carton incorrectly labeled. | Class III | Granules Consumer Health Inc. |
| 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 |
| Oct 5, 2023 | Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail sto... | CGMP Deviations: OTC products were stored outside of labeled temperature requirements. | Class II | Dollar Tree Distribution, Inc. |
| Sep 29, 2023 | ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* ... | Microbial contamination of Non-Sterile Products | Class II | Biomic Sciences, LLC dba ION Intelligence of Na... |
| Sep 29, 2023 | Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA | Microbial contamination of Non-Sterile Products | Class II | Biomic Sciences, LLC dba ION Intelligence of Na... |
| Sep 29, 2023 | ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA | Microbial contamination of Non-Sterile Products | Class I | Biomic Sciences, LLC dba ION Intelligence of Na... |
| Aug 22, 2023 | Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1... | Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity T... | Class II | Sofie Co dba Sofie |
| Mar 31, 2023 | Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever R... | CGMP deviation: product outside labeled storage temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Mar 31, 2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged ... | CGMP deviation: product outside labeled storage temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Mar 31, 2023 | Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAI... | CGMP deviation: product outside labeled storage temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Mar 31, 2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count ... | CGMP deviation: product outside labeled storage temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Dec 30, 2022 | Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10m... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTAB... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/m... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/m... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10m... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/m... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, ... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECT... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial,... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/m... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6m... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, ... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials,... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, ... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
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.