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Browse Drug Recalls

16 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 16 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 16 FDA drug recalls.

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DateProductReasonClassFirm
May 27, 2025 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fres... Lack of Assurance of Sterility Class II Fresenius Medical Care Holdings, Inc.
Jun 18, 2024 DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% D... This product is being recalled due to the tube weld failure presents itself as a slow leak and ca... Class II Fresenius Medical Care Holdings, Inc.
Dec 28, 2023 DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, pack... Lack of Sterility Assurance Class II Fresenius Medical Care Holdings, Inc.
May 23, 2023 Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx onl... Lack of assurance of sterility: The product was potentially exposed to below-recommended storage ... Class II Fresenius Medical Care Holdings, Inc.
Nov 22, 2022 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, U... Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline So... Class II Fresenius Medical Care Holdings, Inc.
Oct 11, 2022 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, U... Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline So... Class II Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack... Temperature Abuse: Product exposed to temperature outside specified limits. Class III Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low C... Temperature Abuse: Product exposed to temperature outside specified limits. Class III Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low C... Temperature Abuse: Product exposed to temperature outside specified limits. Class III Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low C... Temperature Abuse: Product exposed to temperature outside specified limits. Class III Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low ... Temperature Abuse: Product exposed to temperature outside specified limits. Class III Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low ... Temperature Abuse: Product exposed to temperature outside specified limits. Class III Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low ... Temperature Abuse: Product exposed to temperature outside specified limits. Class III Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North Amer... Temperature Abuse: Product exposed to temperature outside specified limits. Class II Fresenius Medical Care Holdings, Inc.
Mar 5, 2020 Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: ... CGMP Deviation: Chemical indicators were not positioned properly during sterilization process. Class II Fresenius Medical Care Holdings, Inc.
Apr 14, 2014 phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufact... Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside... Class II Fresenius Medical Care Holdings, Inc.

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.