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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jun 27, 2014 | fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chlori... | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... | Class II | Healix Infusion Therapy, Inc. |
| Jun 27, 2014 | fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, ... | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... | Class II | Healix Infusion Therapy, Inc. |
| Jun 27, 2014 | fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag,... | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... | Class II | Healix Infusion Therapy, Inc. |
| Jun 27, 2014 | fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG ... | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... | Class II | Healix Infusion Therapy, Inc. |
| Jun 27, 2014 | fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable ba... | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... | Class II | Healix Infusion Therapy, Inc. |
| Feb 13, 2014 | BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-... | Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPiv... | Class II | Healix Infusion Therapy, Inc. |
| Dec 19, 2013 | All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc.... | Lack of Assurance of Sterility | Class II | Abrams Royal Pharamacy |
| Dec 19, 2013 | MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX | Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis | Class I | Abrams Royal Pharamacy |
| Nov 26, 2013 | Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and reli... | Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with ... | Class II | Humco Holding Group, Inc |
| Oct 21, 2013 | Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For ... | Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was fo... | Class I | Medisca Inc. |
| Aug 9, 2013 | All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd... | Lack of Assurance of Sterility | Class II | Specialty Compounding, LLC |
| Aug 9, 2013 | CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% ... | Non Sterility: Microbial contamination | Class I | Specialty Compounding, LLC |
| Jul 19, 2013 | Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bo... | Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... | Class I | Herbal Give Care Llc |
| Jul 19, 2013 | Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle,... | Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... | Class I | Herbal Give Care Llc |
| Jul 19, 2013 | Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plasti... | Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... | Class I | Herbal Give Care Llc |
| Jul 19, 2013 | Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 cap... | Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... | Class I | Herbal Give Care Llc |
| Jul 19, 2013 | Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico... | Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... | Class I | Herbal Give Care Llc |
| Jun 13, 2013 | ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopr... | Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed. | Class II | CareFusion 213, LLC |
| May 31, 2013 | Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, ... | Non-Sterility: The firm's contract testing laboratory found sterility failures. | Class I | Abrams Royal Pharmacy |
| May 13, 2013 | Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as... | Non-Sterility; contract laboratory identified Staphylococcus warneri in the product | Class I | Abrams Royal Pharmacy |
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.