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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
Apr 29, 2016 BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifes... Marketed without an approved NDA/ANDA - presence of undeclared sildenafil. Class I Making It a Lifestyle
Apr 29, 2016 3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifesty... Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. Class II Making It a Lifestyle
Apr 29, 2016 BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it... Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. Class I Making It a Lifestyle
Mar 30, 2016 PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe,... Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case... Class I QuVa Pharma, Inc.
Feb 9, 2016 TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1... Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the pr... Class II Alcon Research, Ltd.
Jan 26, 2016 Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, M... Failed Dissolution Specification: Out of specification dissolution results when testing product s... Class III Apotex Scientific, Inc
Jan 26, 2016 Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, M... Failed Dissolution Specification: Out of specification dissolution results when testing product s... Class III Apotex Scientific, Inc
Jan 26, 2016 Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, M... Failed Dissolution Specification: Out of specification dissolution results when testing product s... Class III Apotex Scientific, Inc
Dec 29, 2015 Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, ... Lack of assurance of sterility Class II TexasStar Pharmacy
Dec 9, 2015 Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-... Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein a... Class I Lucy's Weight Loss (dba. Waisted With Lucy)
Dec 9, 2015 Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bo... Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein a... Class I Lucy's Weight Loss (dba. Waisted With Lucy)
Nov 10, 2015 Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, S... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, R... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, ... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 1... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San A... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, C... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL ... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option C... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, ... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx On... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148,... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, R... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounde... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL,... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San ... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL, Rx Only, Compo... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San A... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compound... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compou... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, ... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, Sa... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Piperacillin/Tazobactam (Zosyn) Accuflo bag, a) 18 g/NS 275 mL b) 4.5 g/NS ... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Ca... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Com... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, Sa... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Car... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 14... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Oct 16, 2015 Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 Mc... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs,... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 M.I.C Injection (Preserved), 25/50/25mg/mL, 50mL vial, Rx only, Downing Labs,... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, ... Lack of Assurance of Sterility Class II Downing Labs, LLC

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.