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
Sep 10, 2018 Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions, Houston, Texas ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions, Houston, Texas ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Ascorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas --- NDC 69... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Te... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas --- NDC 696... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions, Houston, Texas ----... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Methylcobalamin 1 mg/mL a) 10 mL Injectable NDC 69699-1501-10; b) 30 mL Injec... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Phosphate Buffer Solution 0.05 m Aqueous Solution, Pharm D Solutions, Houston... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Sermorelin/GHRP-2/Theanine/Mannitol 15 mg/6 mg/75 mg/300 mg Powder, Pharm D S... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Prostaglandin E1 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas ---... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- N... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG Reconstitued 6000 IU Injectable, Pharm D Solutions, Houston, Texas --- ND... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Epi-Shugarcaine Kit Solution Pharm D Solutions, Houston, Texas --- NDC 69699-... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Pow... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Prostaglandin E1 40 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Tilarginine Acetate 50 mg/mL, 10 mL, Injectable, Pharm D Solutions, Houston, ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 6... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Slenderella Compound Injectable, Pharm D Solutions, Houston, Texas --- NDC 69... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, H... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- ND... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D S... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- ND... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL I... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Aug 28, 2018 Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grai... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Humco Holding Group, Inc
Aug 28, 2018 Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 ... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Humco Holding Group, Inc
Aug 28, 2018 Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grai... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Humco Holding Group, Inc
Aug 27, 2018 Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative ... Subpotent Drug: Product may not have the active ingredient present in the bag. Class I QuVa Pharma, Inc.
Jul 26, 2018 Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grape... Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label Class III Right Value Drug Stores, Inc.
Jun 20, 2018 fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL ... Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated ... Class II Advanced Pharma Inc.
May 17, 2018 Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. C... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded G... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Com... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded G... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy 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.