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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
Mar 15, 2021 Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Jan 29, 2021 Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manuf... Failed Dissolution Specifications Class III Akebia Therapeutics dba Keryx Biopharmaceutials...
Dec 9, 2020 Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufac... CGMP Deviations Class II Akebia Therapeutics dba Keryx Biopharmaceutials...
Jul 10, 2020 Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Man... cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufac... Class II Keryx Biopharmaceuticals, Inc.
Dec 12, 2017 Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufa... Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing ... Class III Keryx Biopharmaceuticals, 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.