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Browse Drug Recalls

8 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 8 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 8 FDA drug recalls.

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DateProductReasonClassFirm
Mar 15, 2021 Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and c... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott La... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Aug 1, 2013 Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by ... Labeling: Incorrect Package Insert; product packaged with outdated version of the insert Class III AbbVie Inc.
Dec 4, 2012 Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per b... Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contain... Class II Abbott Laboratories
Jul 19, 2012 Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottl... Defective Container: A number of Synthroid bottles have a localized thin wall defect on the botto... Class II Abbott Laboratories
Jul 19, 2012 Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottl... Defective Container: A number of Synthroid bottles have a localized thin wall defect on the botto... Class II Abbott Laboratories
Jul 19, 2012 Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bott... Defective Container: A number of Synthroid bottles have a localized thin wall defect on the botto... Class II Abbott Laboratories
May 14, 2012 Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial ... CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have app... Class II Abbott Laboratories

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.