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Browse Drug Recalls

25 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 25 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 25 FDA drug recalls.

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DateProductReasonClassFirm
May 2, 2013 Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Pap... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded b... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding S... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. P... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, co... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectabl... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The C... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compoundin... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding S... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Sh... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Pet... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Com... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compo... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by Th... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Sh... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Sho... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compound... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Sh... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compoundi... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, 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.