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Browse Drug Recalls

119 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 119 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 119 FDA drug recalls.

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DateProductReasonClassFirm
Aug 17, 2026 Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corpo... Presence of Particulate Matter: particulate matter identified as stainless steel particles in the... Class I Baxter Healthcare Corporation
Aug 17, 2026 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 2... Presence of particulate matter: Particulates identified as fiberglass Class I Baxter Healthcare Corporation
Aug 6, 2026 Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY ... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY ... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 unit... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) i... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Sin... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL ... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY ... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per ... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALA... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose C... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 5... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/m... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL)... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 unit... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALA... CGMP Deviations Class II Baxter Healthcare Corporation
Jul 24, 2026 Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Inf... Presence of Particulate Matter Class I Baxter Healthcare Corporation
Dec 22, 2025 Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Ba... Presence of particulate matter: plastic particles from the bottle rim were observed floating into... Class II Baxter Healthcare Corporation
Aug 20, 2025 Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo ... Discoloration Class II Baxter Healthcare Corporation
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
Oct 30, 2024 Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled S... Labeling: Missing Label Class II Baxter Healthcare Corporation
Aug 1, 2024 Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1... Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. Class I Baxter Healthcare Corporation
Jun 17, 2024 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro... Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assemb... Class II Baxter Healthcare 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
Jan 23, 2024 Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL),... Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified ... Class II Baxter Healthcare Corporation
Nov 14, 2023 Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manu... Failed pH Specifications Class II Baxter Healthcare Corporation
Aug 24, 2023 Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL)... CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions dur... Class II Baxter Healthcare Corporation
Aug 14, 2023 Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial,... Labeling: Missing Label; customer complaint received that labels were partially or completely pee... Class III Baxter Healthcare Corporation
Aug 11, 2023 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, p... Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class II Baxter Healthcare Corporation
Aug 11, 2023 Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FL... Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class II Baxter Healthcare Corporation
Mar 15, 2023 Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextro... Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class II Baxter Healthcare Corporation
Mar 15, 2023 Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Amb... Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class II Baxter Healthcare Corporation
Aug 4, 2022 Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container b... Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets ind... Class II Baxter Healthcare Corporation
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 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
Oct 7, 2020 Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 m... Presence of particulate matter in solution - black and transparent particles Class II Baxter Healthcare Corporation
Apr 21, 2020 Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1... Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins Class II Sandoz, Inc
Nov 19, 2019 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare... Lack of Assurance of Sterility: Product has the potential to leak. Class II Baxter Healthcare Corporation
Jul 18, 2019 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter... Lack of Assurance of Sterility: Bags have potential to leak. Class II Baxter Healthcare Corporation
Jun 13, 2019 Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured ... Failed Stability Specifications Class II Baxter Healthcare Corporation
Jan 2, 2019 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextro... Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. Class II Baxter Healthcare Corporation
Oct 15, 2018 Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile si... Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the imp... Class III Baxter Healthcare Corporation
Sep 25, 2018 Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 360... Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... Class III Baxter Healthcare Corporation
Sep 6, 2018 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare ... cGMP Deviation Class II Baxter Healthcare Corporation
Aug 21, 2018 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Co... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 1, 2018 Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% ... Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... Class III Baxter Healthcare Corporation
Aug 1, 2018 Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% ... Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... Class III Baxter Healthcare Corporation

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.