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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
Aug 18, 2025 Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medica... Presence of Particulate Matter Class I B BRAUN MEDICAL INC
Aug 18, 2025 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medi... Presence of Particulate Matter. Class I B BRAUN MEDICAL INC
Mar 31, 2025 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL... Presence of Particulate Matter Class II B. Braun Medical Inc
Nov 25, 2022 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC ... Lack of sterility assurance: Bags have the potential to leak. Class II B. Braun Medical, Inc.
Feb 25, 2022 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun... Lack of sterility assurance: leaking bags Class II B. Braun 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.