Browse Drug Recalls
2,151 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,151 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 2,151 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 10, 2015 | BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/... | Recalled products were made using an active ingredient that was recalled by a supplier due to pen... | Class II | the Compounder |
| Mar 10, 2015 | Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding... | Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin. | Class II | Freedom Pharmaceuticals Inc |
| Mar 6, 2015 | DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) Fuse... | Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia... | Class II | Fusion Pharmaceuticals, LLC |
| Feb 6, 2015 | Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg... | Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-mo... | Class II | Tarmac Products, Inc. |
| Jan 28, 2015 | Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, ... | Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed US... | Class II | Akorn, Inc. |
| Jan 20, 2015 | Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx ... | Non-Sterility: Product tested positive for bacterial contamination. | Class I | Pacifico National, Inc. dba AmEx Pharmacy |
| Jan 20, 2015 | Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, Am... | Non-Sterility: Product tested positive for bacterial contamination. | Class I | Pacifico National, Inc. dba AmEx Pharmacy |
| Dec 31, 2014 | Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Ad... | Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 3... | Class II | Valeant Pharmaceuticals North America LLC |
| 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. |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor,... | Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate ... | Class II | Tropichem Research Labs, 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 | 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 | Robert Wood Johnson University (NJ) Neonatal Starter 5% Dextrose, Trophamine ... | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Class I | Central Admixture Pharmacy Services, Inc. |
| Dec 17, 2014 | Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10... | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Class I | Central Admixture Pharmacy Services, Inc. |
| Dec 17, 2014 | St Lukes East Lees Summit (MO) Protein Bag,Trophamine 5g, Dextrose 10%, Addit... | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Class I | Central Admixture Pharmacy Services, Inc. |
| Dec 17, 2014 | Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dex... | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Class I | Central Admixture Pharmacy Services, Inc. |
| Dec 17, 2014 | Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine... | 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) Trophamine UAC Solution, Trophamine 3.2g,... | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Class I | Central Admixture Pharmacy Services, Inc. |
| Dec 17, 2014 | Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% without Ca, Trophamine 12g, ... | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Class I | Central Admixture Pharmacy Services, Inc. |
| Nov 14, 2014 | Homatropine Methylbromide active pharmaceutical ingredient packaged in varyin... | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... | Class II | Attix Pharmaceuticals |
| Nov 14, 2014 | Methyl Folate Calcium active pharmaceutical ingredient packaged in varying gr... | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... | Class II | Attix Pharmaceuticals |
| Nov 14, 2014 | Diphenylcyclopropenone active pharmaceutical ingredient packaged in varying g... | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... | Class II | Attix Pharmaceuticals |
| Nov 14, 2014 | Tolvaptan active pharmaceutical ingredient packaged in varying grams or kg in... | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... | Class II | Attix Pharmaceuticals |
| Nov 14, 2014 | Lidocaine HCl active pharmaceutical ingredient packaged in varying grams or k... | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... | Class II | Attix Pharmaceuticals |
| Nov 14, 2014 | 4-Aminopyridine active pharmaceutical ingredient packaged in varying grams or... | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... | Class II | Attix Pharmaceuticals |
| Nov 14, 2014 | Vidarbine Monophosphate active pharmaceutical ingredient packaged in varying ... | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05... | Class II | Attix Pharmaceuticals |
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.