Browse Drug Recalls

695 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 695 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 695 FDA drug recalls in PA.

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DateProductReasonClassFirm
Dec 17, 2014 Olathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamin... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Advocate Good Samaritan Hospital (IL) TPN Dextrose 5% Trophamine 2%, Tropham... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Addi... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 The Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% D... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextros... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, D... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, T... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Abington Memorial Hospital (PA) TPN Neonatal Starter> 1Kg, Amino Acids, Neona... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextro... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamin... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Abington Memorial Hospital (PA) TPN Neonatal Starter 0.6-0.99 Kg, Amino Acid... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Tropha... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM, Trophamine 4g/dL, D... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Bayshore Medical Center (TX) 5% Dextrose Starter Neo TPN, Trophamine 2.4% , D... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, A... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Truman Medical Center Lakewood (MO) Starter TPN, Trophamine 5.25g, Dextrose 1... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag, Trophamine 3% Dext... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dext... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Tr... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additi... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acid... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dext... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Oct 8, 2014 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFAT... Failed Impurities/Degradation Specifications: Out of specification for unknown impurities. Class II Teva Pharmaceuticals USA
Jul 16, 2014 Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Ch... Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspens... Class II Bio-pharm, Inc.
Jun 17, 2014 Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15... Failed Impurities/Degradation Specifications: out of specification impurity test results. Class III Teva Pharmaceuticals USA
Jun 17, 2014 Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 ... Failed Impurities/Degradation Specifications: out of specification impurity test results. Class III Teva Pharmaceuticals USA
Jun 17, 2014 Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyc... Failed Impurities/Degradation Specifications: out of specification impurity test results. Class III Teva Pharmaceuticals USA
Jun 17, 2014 Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.... Failed Impurities/Degradation Specifications: out of specification impurity test results. Class III Teva Pharmaceuticals USA
Jun 5, 2014 Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, ... Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets... Class II Teva Pharmaceuticals USA
May 29, 2014 Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for T... Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one... Class II Teva Pharmaceuticals USA
May 5, 2014 Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang P... Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain und... Class I Eugene Oregon, Inc.
May 5, 2014 MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Spr... Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain und... Class I Eugene Oregon, Inc.
May 5, 2014 Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distribut... Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a ND... Class II Axcentria Pharmaceuticals, LLC
May 5, 2014 AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei ... Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain und... Class I Eugene Oregon, Inc.
May 1, 2014 Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Ba... Failed Impurities/Degradation Specifications: this product is being recalled due to an out of spe... Class II Teva Pharmaceuticals USA
Apr 23, 2014 QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered... Defective Delivery System; defective valve Class II Teva Pharmaceuticals USA
Apr 22, 2014 Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 4279... Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are ... Class II SigmaPharm Laboratories LLC
Apr 7, 2014 BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx on... Failed Impurities/Degradation Specifications: High out of specification impurity test results wer... Class II Teva Pharmaceuticals USA
Apr 7, 2014 BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx on... Failed Impurities/Degradation Specifications: High out of specification impurity test results wer... Class II Teva Pharmaceuticals USA
Apr 7, 2014 Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manuf... Failed pH Specifications: product was too acidic. Class II Piramal Critical Care, Inc.
Apr 1, 2014 triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP... Failed Impurities/Degradation Specifications: This recall is due to out of specification for impu... Class II Teva Pharmaceuticals USA
Mar 28, 2014 MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Sp... Marketed Without an Approved NDA/ANDA; Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los ... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orland... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, 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.