Browse Drug Recalls
1,309 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,309 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 1,309 FDA drug recalls in 2014.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 ... | Subpotent Drug | Class II | Neolpharma, 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. |
| Dec 16, 2014 | J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ ... | Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red... | Class II | Jaymac Pharmaceuticals L.L.C. |
| Dec 15, 2014 | Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45... | Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... | Class II | Actavis Elizabeth LLC |
| Dec 15, 2014 | Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14... | Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... | Class II | Actavis Elizabeth LLC |
| Dec 15, 2014 | Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactu... | Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... | Class II | Actavis Elizabeth LLC |
| Dec 12, 2014 | ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-... | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... | Class I | Anabolic Science Labs, LLC |
| Dec 12, 2014 | M1-ALPHA LABS MEGA MASS BUILDER (M1A, Methyl-1-Etiocholenolol- 20mg, Epietioc... | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... | Class I | Anabolic Science Labs, LLC |
| Dec 12, 2014 | 7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), C... | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... | Class I | Anabolic Science Labs, LLC |
| Dec 12, 2014 | PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg: 13-dimethyl-1,2,7,8,9,11,12,14,1... | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... | Class I | Anabolic Science Labs, LLC |
| Dec 12, 2014 | Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vial... | Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial. | Class II | Right Value Drug Stores, Inc. |
| Dec 12, 2014 | Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American ... | Presence of Particulate Matter; preservative may not have dissolved completely or precipitated ou... | Class II | American Specialty Pharmacy |
| Dec 12, 2014 | M14-MENT ADVANCED MASS BUILDER (7a-Methyl-estra-4-en-3,17-dione MENT 5mg, M14... | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... | Class I | Anabolic Science Labs, LLC |
| Dec 12, 2014 | SWOLL-250 SUPER MASS BUILDER QUAD STACK (18-Methylestr-4-en-3-one-17b-ol 15mg... | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... | Class I | Anabolic Science Labs, LLC |
| Dec 12, 2014 | HALO-70 MEGA MASS BUILDER (4-chloro-17a-methyl-androst-1,4-diene-3b,17b-diol ... | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... | Class I | Anabolic Science Labs, LLC |
| Dec 9, 2014 | Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size:... | Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 ... | Class III | Akorn, Inc. |
| Dec 9, 2014 | sulfur8(R) medicated anti-dandruff conditioner, dandruff treatment for Braids... | Failed pH specification: Product pH test value of 5.72 failed to meet its product specification o... | Class III | J. Strickland and Co |
| Dec 5, 2014 | BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactur... | Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or ill... | Class III | Eisai Inc |
| Dec 5, 2014 | Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sand... | Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an i... | Class III | Sandoz Incorporated |
| Dec 4, 2014 | Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: M... | Failed Impurities/Degradation Specifications: Product failed a known impurity specification. | Class III | Micro Labs Usa, 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.