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Browse Drug Recalls

54 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 54 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 54 FDA drug recalls.

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DateProductReasonClassFirm
Sep 21, 2012 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVI... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II Baxter Healthcare Corp.
Sep 21, 2012 5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product cod... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II Baxter Healthcare Corp.
Sep 21, 2012 Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, produ... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II Baxter Healthcare Corp.
Sep 21, 2012 10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Ba... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II Baxter Healthcare Corp.

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.