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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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
May 23, 2019 Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 m... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50m... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 Sout... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loo... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only,... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 130... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South L... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South L... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
Apr 26, 2019 HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% ... Sub-potency Class II Advanced Pharma Inc.
Apr 15, 2019 Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx ... Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterili... Class II Iso-Tex Diagnostics, Inc
Apr 5, 2019 Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufa... Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undecla... Class I Brian P. Richardson
Mar 19, 2019 Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... cGMP Deviations Class II Allergan Sales, LLC
Mar 13, 2019 Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Ster... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Sol... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectabl... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Soluti... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable S... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile singl... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
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.

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.