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 |
|---|---|---|---|---|
| Sep 12, 2016 | Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottle... | Superpotent Drug and Subpotent Drug; potency failures obtained | Class II | MOORE'S COMPOUNDING PHARMACY |
| Jul 19, 2016 | Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogena... | Lack of Assurance of Sterility | Class II | Talon Compounding Pharmacy |
| Jul 1, 2016 | Dream Body 450 mg 30 capsules in a plastic screw on top bottle | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Class II | Dream Body Weight Loss |
| Jul 1, 2016 | Dream Body Advanced 400 mg 30 capsules in brown foil packets. | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Class II | Dream Body Weight Loss |
| Jul 1, 2016 | Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Class II | Dream Body Weight Loss |
| Jun 30, 2016 | TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional ... | Failed Content Uniformity Specifications | Class II | Allergan Sales, LLC |
| Jun 30, 2016 | TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for O... | Failed Content Uniformity Specifications | Class II | Allergan Sales, LLC |
| May 19, 2016 | Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Markete... | Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing. | Class III | Galderma Laboratories, L.P. |
| May 11, 2016 | aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topi... | CGMP Deviations | Class II | The Aloe Source |
| May 10, 2016 | Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvin... | Failed Content Uniformity Specifications. | Class II | Allergan Sales, LLC |
| May 10, 2016 | Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03... | Failed Content Uniformity Specifications. | Class II | Allergan Sales, LLC |
| 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 |
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.