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 |
|---|---|---|---|---|
| Jan 24, 2014 | Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distribu... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, dist... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | Magic Slim capsules, supplied in 60 count bottles, distributed by MyNicKnaxs,... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Anoth... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 13, 2014 | PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distribute... | Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, N... | Class I | HUMAN SCIENCE FOUNDATION |
| Jan 10, 2014 | DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, ... | Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the... | Class I | Hospira Inc. |
| Jan 9, 2014 | SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bay... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc.... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also ... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manuf... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Po... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Dec 23, 2013 | Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose... | Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass co... | Class I | Hospira Inc. |
| Dec 23, 2013 | Burn 7 Capsules, supplied in 30 capsules bottle | Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 diet... | Class I | Deseo Rebajar |
| Dec 19, 2013 | MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX | Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis | Class I | Abrams Royal Pharamacy |
| Dec 12, 2013 | Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, ... | Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination fo... | Class I | Zions RX Formulations Services LLC dba RX Formu... |
| Dec 10, 2013 | Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscor... | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphth... | Class I | Slim Beauty USA |
| Dec 10, 2013 | Dr. Ming's Chinese Capsule (Ginger 50 mg, Camellia Sinensis 50 mg, Malus Dome... | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphth... | Class I | Slim Beauty USA |
| Dec 10, 2013 | Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe... | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutram... | Class I | Slim Beauty USA |
| Nov 21, 2013 | Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Containe... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 m... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx... | Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to... | Class I | Baxter Healthcare Corp. |
| Nov 21, 2013 | 0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB C... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX... | Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due t... | Class I | Baxter Healthcare Corp. |
| Nov 21, 2013 | Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No.... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, C... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Conta... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 19, 2013 | P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack ... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared activ... | Class I | Tendex |
| Nov 19, 2013 | NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared activ... | Class I | Tendex |
| Nov 19, 2013 | vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules... | Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in... | Class I | Vitality Research Labs LLC |
| Nov 18, 2013 | 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass conta... | Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and ... | Class I | Baxter Healthcare Corp. |
| Nov 18, 2013 | eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Compan... | Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietar... | Class I | SS Wholesale Inc. dba Jobbers Wholesale |
| Nov 18, 2013 | Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL... | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Class I | Baxter Healthcare Corp. |
| Nov 18, 2013 | RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fo... | Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclar... | Class I | Fossil Fuel Products, LLC |
| Nov 18, 2013 | Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% De... | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Class I | Baxter Healthcare Corp. |
| Nov 18, 2013 | MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterpr... | Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a diet... | Class I | SS Wholesale Inc. dba Jobbers Wholesale |
| Nov 18, 2013 | Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1... | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Class I | Baxter Healthcare Corp. |
| Nov 18, 2013 | Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Dis... | Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary ... | Class I | SS Wholesale Inc. dba Jobbers Wholesale |
| Nov 13, 2013 | Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/St... | Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with... | Class I | Brookfield Prescription Center Inc |
| Nov 7, 2013 | Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Die... | Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this di... | Class I | Deseo Rebajar |
| Nov 4, 2013 | Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300... | Presence of Particulate Matter: Failed the appearance test for the presence of visible particles. | Class I | Alexion Pharmaceuticals, Inc. |
| Nov 4, 2013 | Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45... | Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclare... | Class I | IQ Formulations, LLC |
| Oct 21, 2013 | Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For ... | Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was fo... | Class I | Medisca 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.