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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.