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.

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DateProductReasonClassFirm
Aug 25, 2015 Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-... Lack of Assurance of Sterility: Failed preservative effectiveness testing Class II Apotex Inc.
Aug 21, 2015 Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, pa... Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling pr... Class II Nephron Pharmaceuticals Corp.
Aug 17, 2015 Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured b... Lack of Assurance of Sterility: Failed preservative effectiveness testing. Class II Bausch & Lomb, Inc.
Aug 17, 2015 Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 1... Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to... Class I Hartley Medical Center Pharmacy, Incorporated
Aug 17, 2015 Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupi... Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to... Class I Hartley Medical Center Pharmacy, Incorporated
Jul 24, 2015 PROGESTERONE, Pellet, 50mg, Rx only, JD & SN Inc, DBA Moses Lake Professional... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 METHIONINE/CHOLINE/INOSITOL, injectable Solution, 25/50/50 MG/ML, 10 mL syrin... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 PAPAVERINE/PHENTOLAMINE, Injectable Solution, 30MG/1MG/ML, 10 mL syringe, Rx... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 HYDROXYPROGESTERONE CAPROATE OIL, injectable Solution, 250 mg/mL, syringe siz... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TESTOSTERONE/ANASTROZOLE, Pellet, 200/13 mg, Rx only, JD & SN Inc, DBA Moses ... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 ESTRADIOL, Pellet, 3 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional P... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 CHORIONIC GONADOTROPIN, Injectable Solution, 1000 UNITS/0.1 mL, 1 mL vial, Rx... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TRIMIX, injectable Solution, 30MG/1MG/20MCG, 10mL syringe, Rx only, JD & SN I... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 ESTRADIOL, Pellet, 75 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional ... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 CHORIONIC GONADOTROPIN, Injectable Solution, 5000 UNITS/0.1 mL, vial sizes: 5... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 METHYLCOBALAMIN, Injectable Solution, 15 MG/ML, syringe sizes: 5 mL; 6 mL; 10... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 CYANOCOBALAMIN MDV (COMPOUNDED), Injectable Solution, 1 MG/ML per syringe, Rx... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 MEDROXYPROGESTERONE ACETATE, injectable Solution,150MG/ML, 10mL syringe, Rx o... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 ESTRADIOL, Injectable Solution, 20 mg/mL, 5 mL syringe, Rx only, JD & SN Inc... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 ETHYL ALCOHOL (STERILE FOR INJECTION) 100%, Injectable Solution, 200 PROOF, 3... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 ESTRADIOL, Pellet, 12 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional P... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/5.4/5.4MG/9ML, 9mL syringe, ... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TESTOSTERONE, Pellet, 76 mg, Rx only, JD & SN Inc, DBA Moses Lake Profession... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 HYDROXYCOBALAMINE/METHYLCOBALAMINE PF UNIT DOSE, Injectable Solution, 1.5/1.5... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 500 UNITS/0.5ML per s... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TESTOSTERONE/ANASTROZOLE, Pellet, 120/8 mg, Rx only, JD & SN Inc, DBA Moses L... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 GLYCOPYRROLATE, Injectable Solution, 0.2 mg/mL, 300 mL syringe, Rx only, JD &... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 SODIUM TETRADECYL SULFATE, Injectable Solution, 3%, 2 mL syringe, Rx only, JD... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 EDETATE CALCIUM DISODIUM (SINGLE USE ONLY), Injectable Solution, 300 mg/mL, 1... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 HYDROXOCOBALAMIN MULTIDOSE VIAL, Injectable Solution, 5 mg/mL, syringe sizes:... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 ESTRADIOL, Pellet, 20 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional P... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 PROGESTERONE, Pellet, 100 mg, Rx only, JD & SN Inc, DBA Moses Lake Profession... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 DEXPANTHENOL, Injectable Solution, 250 MG/ML, 30 mL syringes, Rx only, JD & S... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 ESTRADIOL, Pellet, 18 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional P... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TRIMIX, injectable Solution, 30MG/2MG/20MCG, syringe size: 10mL, Rx only, JD ... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 CHORIONIC GONADOTROPIN, Injectable Solution, 200 UNITS/0.1 ML, vial sizes: 4 ... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TESTOSTERONE, Pellet, 200 mg, Rx only, JD & SN Inc, DBA Moses Lake Professio... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TESTOSTERONE PROPRIONATE, Injectable Solution, 100 mg/mL, syringe size: 10mL,... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 ALPROSTADIL/PROCAINE, Injectable Solution, 40 MCG/0.1%/ML, 10 mL and 20 mL vi... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TESTOSTERONE CYPIONATE (COMPOUNDED), Injectable Solution, 200 MG/ML, syringe ... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TESTOSTERONE CYPIONATE FOR SUBQ INJECTION, Injectable Solution, 200 mg/mL, sy... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 METHYLCOBALAMIN, injectable Solution, 10 MG/ML, syringe sizes: 10mL; 22.5mL; ... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TESTOSTERONE, Pellet, 60 mg, Rx only, JD & SN Inc, DBA Moses Lake Profession... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TESTOSTERONE, Pellet, 130 mg, Rx only, JD & SN Inc, DBA Moses Lake Professio... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 ESTRADIOL, Pellet, 30 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional ... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TESTOSTERONE, Pellet, 120 mg, Rx only, JD & SN Inc, DBA Moses Lake Professio... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 METHYLCOBALAMIN/HYDROXOCOBALAMIN PRESERVATIVE FREE UNIT DOSE SYRINGES, Inject... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TESTOSTERONE, Pellet, 112 mg, Rx only, JD & SN Inc, DBA Moses Lake Professio... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 TESTOSTERONE, Pellet, 106 mg, Rx only, JD & SN Inc, DBA Moses Lake Professio... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy
Jul 24, 2015 ESTRADIOL, Pellet, 9 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional P... Lack of Assurance of Sterility; all sterile human compounded drugs within expiry Class II JD & SN Inc., dba Moses Lake Professional Pharmacy

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.