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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Oct 29, 2025 POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly con... Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc... Class I Otsuka ICU Medical LLC
Oct 29, 2025 POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly co... Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc... Class I Otsuka ICU Medical LLC
Oct 27, 2025 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake... Lack of Assurance of Sterility: Potential for flexible container leaks. Class II Otsuka ICU Medical LLC
Feb 13, 2025 POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case,... Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain ... Class I ICU Medical, Inc.
Feb 13, 2025 POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container... Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may... Class I ICU Medical, Inc.
Nov 9, 2022 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ... Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which ... Class II ICU Medical Inc
Mar 9, 2021 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manu... Presence of particulate matter.one confirmed customer report of particulate matter within two se... Class II ICU Medical 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.