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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
Mar 13, 2019 fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, Q... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 3... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 11, 2019 Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx ... Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, there... Class II Iso-Tex Diagnostics, Inc
Feb 6, 2019 Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of... Labeling: Incorrect expiration date. Class II Advanced Pharma Inc.
Feb 6, 2019 Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... Class III Advanced Pharma Inc.
Feb 6, 2019 Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Inje... Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... Class III Advanced Pharma Inc.
Feb 6, 2019 Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... Class III Advanced Pharma Inc.
Jan 15, 2019 HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodiu... Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/5... Class II Advanced Pharma Inc.
Dec 10, 2018 Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, ... Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. Class III CBI Laboratories, Inc.
Dec 10, 2018 Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenz... Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. Class III CBI Laboratories, Inc.
Nov 29, 2018 Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable So... Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per ... Class I Advanced Pharma Inc.
Nov 21, 2018 Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 m... Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium C... Class III QuVa Pharma, Inc.
Nov 19, 2018 Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South ... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Pharm D Solutions, LLC
Nov 2, 2018 curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Ep... Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... Class II Bound Tree Medical, LLC
Nov 2, 2018 curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 ... Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... Class II Bound Tree Medical, LLC
Nov 2, 2018 Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarn... Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... Class II Bound Tree Medical, LLC
Nov 2, 2018 Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contai... Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... Class II Bound Tree Medical, LLC
Nov 1, 2018 Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe... Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May... Class III Bound Tree Medical, LLC
Nov 1, 2018 curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains... Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 e... Class II Bound Tree Medical, LLC
Sep 25, 2018 Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw ... Labeling Not Elsewhere Classified: Misbranding. Class III Right Value Drug Stores, Inc.
Sep 25, 2018 Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pi... Labeling Not Elsewhere Classified: Misbranding. Class III Right Value Drug Stores, Inc.
Sep 25, 2018 Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw ... Labeling Not Elsewhere Classified: Misbranding. Class III Right Value Drug Stores, Inc.
Sep 25, 2018 Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top p... Labeling Not Elsewhere Classified: Misbranding. Class III Right Value Drug Stores, Inc.
Sep 10, 2018 Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Hou... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D So... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D S... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10 Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution, Pharm D S... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texa... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Zinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- ND... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05 Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Magnesium 40 gm/ns 1000 mL IV, Pharm D Solutions, Houston, Texas --- NDC 6969... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas -... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Glycerin 72% (Lidocaine/Epi 2:1) Injectable, Pharm D Solutions, Houston, Texa... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Sterile Water 50 mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- N... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 0.9% Sodium Chloride for Injection, 50 mL bags, Pharm D Solutions, Houston, T... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15;... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Ho... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Prostaglandin E1 80 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Pyridoxine 100 mg/mL, 30 mL MDV Injectable, Pharm D Solutions, Houston, Texas... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG 50,000 unit/0.3 gm Mannitol Lyophilized Powder Pharm D Solutions, Houston... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Sermorelin/GHRP-2/GHRP-6 Mannitol 9 mg/9 mg/9 mg/300 mg Powder, Pharm D Solut... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Phenol 5% and Glycerin Aqueous Solution 10 mL Injection, Pharm D Solutions, H... Lack of Assurance of Sterility Class II Pharm D Solutions, 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.