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
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.