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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
Oct 18, 2013 Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compo... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 18, 2013 Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr B... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 18, 2013 Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Su... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 18, 2013 PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compou... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 18, 2013 Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 260... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge

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.