Browse Drug Recalls

972 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 972 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 972 FDA drug recalls in TX.

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DateProductReasonClassFirm
Oct 16, 2015 DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Sui... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Ph... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 Mc... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Thiotic Acid Injection, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 M... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwe... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial, Rx only, Downing Labs... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 TNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial, Rx only, D... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McE... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Su... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Glucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001... Lack of Assurance of Sterility Class II Downing Labs, LLC
Sep 25, 2015 Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in ... Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and da... Class I Tf Supplements
Sep 25, 2015 RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and da... Class I Tf Supplements
Sep 23, 2015 Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-cou... Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. Class I Lucy's Weight Loss (dba. Waisted With Lucy)
Sep 23, 2015 Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bot... Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. Class I Lucy's Weight Loss (dba. Waisted With Lucy)
Sep 23, 2015 Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged ... Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. Class I Lucy's Weight Loss (dba. Waisted With Lucy)
Sep 22, 2015 Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20... Cross Contamination With Other Products: Potential cross-contamination of cephalosporin. Class II Midway Importing, Inc
Sep 4, 2015 Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare ... Chemical Contamination: Naphthalene compound identified in the product after complaints of a petr... Class II Healthpoint, Ltd
Aug 24, 2015 Refresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Oin... Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... Class II Allergan Sales, LLC
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

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.