Browse Drug Recalls
1,732 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,732 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 1,732 FDA drug recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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. |
| 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 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 | 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 | 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 | 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 | 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 | 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 4, 2014 | 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, ... | Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue ... | Class I | Baxter Healthcare Corp |
| Dec 3, 2014 | MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake F... | Failed Stability Specifications: Product is subpotent and has out of specification known and unkn... | Class I | Hospira Inc. |
| Nov 3, 2014 | Forever Beautiful BEE POLLEN, capsules, 250mg in 60-count bottles, 900 Common... | Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phen... | Class I | REFA Enterprises, LLC |
| Nov 3, 2014 | Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwe... | Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phen... | Class I | REFA Enterprises, LLC |
| Oct 16, 2014 | 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Fr... | Presence of particulate matter: A returned customer sample was evaluated and found to have human ... | Class I | Hospira Inc. |
| Oct 6, 2014 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patie... | Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. | Class I | Hospira Inc. |
| Sep 11, 2014 | HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.... | Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between ... | Class I | Hospira Inc. |
| Sep 5, 2014 | Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Ph... | Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... | Class I | Pharmacy Creations |
| Sep 5, 2014 | Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharm... | Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... | Class I | Pharmacy Creations |
| Sep 5, 2014 | Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution... | Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... | Class I | Pharmacy Creations |
| Sep 5, 2014 | Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx... | Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... | Class I | Pharmacy Creations |
| Aug 8, 2014 | CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only,... | Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at th... | Class I | Cubist Pharmaceuticals, Inc. |
| Aug 7, 2014 | Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro... | Presence of Particulate Matter: particulate matter was found during the manufacturing process. | Class I | Baxter Healthcare Corp. |
| Aug 1, 2014 | CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufact... | Presence of Particulate Matter: Potential presence of glass particulate matter in the vials. | Class I | Cubist Pharmaceuticals, Inc. |
| Jul 29, 2014 | Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Singl... | Presence of Particulate Matter: The product was discolored and contained visible particulates (ir... | Class I | Hospira Inc. |
| Jul 24, 2014 | Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administra... | Non-Sterility: The recalled lot failed sterility testing. | Class I | Physician Preferred Medical, LLC |
| Jul 18, 2014 | N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 | Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense. | Class I | Unique Pharmaceutical, Ltd |
| Jul 11, 2014 | 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Si... | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Class I | Baxter Healthcare Corp. |
| Jul 11, 2014 | Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Con... | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics | Class I | Baxter Healthcare Corp. |
| Jul 11, 2014 | 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container ba... | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Class I | Baxter Healthcare Corp. |
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.