Browse Drug Recalls

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

Clear
DateProductReasonClassFirm
Oct 17, 2018 Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (ND... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-0... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-11... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 15, 2018 Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only,... Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle Class II Heritage Pharmaceuticals, Inc.
Oct 8, 2018 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 15... Lack of Assurance of Sterility; bags have the potential to leak Class II ICU Medical Inc
Oct 8, 2018 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC... Lack of Assurance of Sterility; bags have the potential to leak Class II ICU Medical Inc
Sep 20, 2018 Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Steril... Lack of assurance of sterility: loss of container integrity. Class II Pfizer Inc.
Sep 19, 2018 Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, ... Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. Th... Class II Pfizer Inc.
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 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 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 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 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 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 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 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 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 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 Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas ---- NDC 69699... 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 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 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 Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable... 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 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 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 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 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 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 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 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 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 Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm... 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 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 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 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 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 Levocarnitine 170 mg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC... 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 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 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 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 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 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 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 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 Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texa... 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.