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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
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
Apr 19, 2013 Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluro... Non-Sterility Class I Abrams Royal Pharmacy
Apr 17, 2013 NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible ... Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopene... Class II Unique Pharmaceutical, Ltd
Apr 15, 2013 Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVisio... Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assuranc... Class I NuVision Pharmacy, Inc.
Apr 15, 2013 HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVisio... Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assuranc... Class I NuVision Pharmacy, Inc.
Apr 15, 2013 The firm is recalling all lots of sterile products compounded by the pharmacy... Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assura... Class II Apothecure, Inc
Mar 28, 2013 Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Prese... Lack of Assurance of Sterility; reports of adverse events after injection Class II NuVision Pharmacy, Inc.
Mar 4, 2013 Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Mar 4, 2013 SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodiu... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Mar 4, 2013 FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net ... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Mar 4, 2013 SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators ... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Mar 4, 2013 Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 S... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Mar 4, 2013 SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP ... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Jan 23, 2013 Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manuf... Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect ... Class III Mission Pharmacal Co
Jan 17, 2013 Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and reli... Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminat... Class II Humco Holding Group, Inc
Aug 15, 2012 Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For ... Subpotent; fluocinolone acetonide. Class III Galderma Laboratories, L.P.
May 18, 2012 a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules bl... Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tada... Class I InSo-Independent Contractor for West Coast Nutr...
Apr 23, 2012 ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alc... Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material tha... Class II Carefusion 213, Llc
Mar 20, 2012 DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distribut... Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subp... Class III Quadrant Chemical Corporation
Nov 8, 2011 ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative S... Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (op... Class II Carefusion 213, Llc
May 27, 2011 ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750m... Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. Class II A B Nutrition, Inc.
May 27, 2011 PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams P... Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. Class II A B Nutrition, Inc.
May 27, 2011 PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 8... Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. Class II A B Nutrition, Inc.

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.