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Browse Drug Recalls

942 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 942 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 942 FDA drug recalls in TX.

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DateProductReasonClassFirm
Aug 24, 2015 BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment... Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... Class II Allergan Sales, LLC
Aug 24, 2015 FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan... Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... Class II Allergan Sales, LLC
Aug 24, 2015 Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant E... Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... Class II Allergan Sales, LLC
Jul 6, 2015 Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Join... Subpotent Drug: menthol and methyl salicylate below specification Class III BioComp Pharma, Inc.
Jun 23, 2015 CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS R... Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications. Class III Abrams Royal Pharmacy II, LLC
Jun 3, 2015 Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic ... Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutra... Class I Centro Naturista
Jun 3, 2015 Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic ... Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutra... Class I Centro Naturista
Apr 30, 2015 Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sun... Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. Class II Mission Pharmacal Co
Apr 30, 2015 Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetam... Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. Class II Mission Pharmacal Co
Dec 26, 2014 Aztreonam 1 gram in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Gentamicin various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 L-cysteine various strengths Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Cefepime various strengths in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Tobramycin various strengths in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Diphenhydramine 50 mg/ml vials Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Dehydrated alcohol vials Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Linezolid various strengths in dextrose Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Immune globulin g human various strengths Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Levofloxacin various strengths in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Dopamine various strengths in dextrose Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Cefazolin various strengths in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Liposomal Amphotericin B 130 mg in dextrose bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Magnesium sulfate various strengths in sodium chloride Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Milrinone various strengths in dextrose Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Vancomycin various strengths in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Tigecycline various strengths in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Deferoxamine various strengths in normal saline Lack of sterility assurance. Class III Walgreens Infusion Services
Dec 26, 2014 Dobutamine various strengths in dextrose Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Folic acid 1 mg/ 0.2 ml pre-drawn syringes Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Cefoxitin various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Imipenem/ cilastatin various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Thiamine 100 mg/ ml vials Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Meropenem various strengths in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Amikacin various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Daptomycin various strengths in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Ranitidine various strengths in syringes Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Cefuroxime various strengths in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Ertapenem various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Total parenteral nutrition various strengths Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Caspofungin various strengths in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Piperacillin/ tazobactam various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Ceftazidime various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Nafcillin various strengths in sterile water for injection bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Ceftriaxone various strengths in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Acyclovir various strengths in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 12, 2014 Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vial... Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial. Class II Right Value Drug Stores, Inc.
Dec 12, 2014 Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American ... Presence of Particulate Matter; preservative may not have dissolved completely or precipitated ou... Class II American Specialty Pharmacy
Oct 24, 2014 Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, Car... Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to h... Class III CareFusion 213, LLC
Jul 18, 2014 N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense. Class I Unique Pharmaceutical, Ltd
Jul 18, 2014 All sterile products within expiry Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices t... Class II Unique Pharmaceutical, Ltd

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.