Browse Drug Recalls
953 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 953 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 953 FDA drug recalls in TX.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
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.