Browse Drug Recalls

1,528 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,528 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 1,528 FDA drug recalls in FL.

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Date	Product	Reason	Class	Firm
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.
Apr 24, 2013	Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactu...	Marketed without an Approved NDA/ANDA.	Class II	Insight Instruments, Inc.
Apr 17, 2013	Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmac...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Comprehensive injection #4 - SS varied injectable Injectable Balanced Soluti...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a divisio...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmac...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compoun...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, ...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharm...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a di...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a d...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharma...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmac...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Ax...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Ph...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pha...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharma...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compou...	Lack of Sterility Assurance	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy ...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a divisio...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compo...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compoundi...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy ...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013	Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a divisi...	Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th...	Class II	Axium Healthcare Pharmacy dba Balanced Solution...

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.