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Browse Drug Recalls

15 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 15 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 15 FDA drug recalls.

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DateProductReasonClassFirm
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
Sep 3, 2021 AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible co... Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous ... Class I 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
May 8, 2020 LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira... Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matt... Class I ICU Medical Inc
Oct 25, 2019 LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira... Presence of Particulate Matter. Class I ICU Medical Inc
Oct 25, 2019 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira... Presence of Particulate Matter. Class I ICU Medical Inc
Feb 4, 2019 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hos... CGMP Deviations Class II ICU Medical Inc
Oct 8, 2018 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC... Lack of Assurance of Sterility; bags have the potential to leak Class II ICU Medical Inc
Oct 8, 2018 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 15... Lack of Assurance of Sterility; bags have the potential to leak Class II ICU Medical Inc
May 31, 2018 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, I... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
Jul 26, 2017 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container... Presence of Particulate Matter; stainless steel 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.