Browse Drug Recalls
1,733 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,733 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 1,733 FDA drug recalls in 2015.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 31, 2015 | Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) ... | Failed Impurities/Degradation Specifications; 9 month stability timepoint | Class III | Sandoz Inc |
| Dec 31, 2015 | NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chlor... | Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration | Class III | Pharmedium Services, LLC |
| Dec 31, 2015 | NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chlor... | Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration | Class III | Pharmedium Services, LLC |
| Dec 29, 2015 | Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, ... | Lack of assurance of sterility | Class II | TexasStar Pharmacy |
| Dec 29, 2015 | Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous adm... | Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture. | Class I | Complete Pharmacy and Medical Solutions LLC |
| Dec 24, 2015 | Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufac... | Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet. | Class II | Macleods Pharma Usa Inc |
| Dec 24, 2015 | Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Comp... | Lack of Assurance of Sterility | Class II | Amerita Specialty Infusion Services |
| Dec 24, 2015 | IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syr... | Lack of Assurance of Sterility | Class II | Amerita Specialty Infusion Services |
| Dec 23, 2015 | La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufac... | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... | Class I | Bee Xtreme |
| Dec 23, 2015 | Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured f... | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... | Class I | Bee Xtreme |
| Dec 23, 2015 | APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclus... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Nuway Distributors, LLC |
| Dec 23, 2015 | Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for... | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... | Class I | Bee Xtreme |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, ... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spr... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Sp... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 21, 2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Dec 21, 2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Dec 21, 2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Dec 21, 2015 | Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bo... | Failed Dissolution Specifications: low test results at the 18 month time-point | Class II | Teva North America |
| Dec 18, 2015 | Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softge... | Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg. | Class III | National Vitamin Co Inc |
| Dec 17, 2015 | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 f... | Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result de... | Class III | Bio-pharm, Inc. |
| Dec 17, 2015 | VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Suppl... | Defective Delivery System: Product may contain leaking capsules. | Class III | Virtus Pharmaceuticals, Llc |
| Dec 15, 2015 | ZI XIU TANG BEAUTY FACE & FIGURE Capsules, 250 mg, 60-count bottles | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Asset extreme+PLUS Capsules, 500 mg, 30-count bottles, Distributed by Descor... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bu... | Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in th... | Class I | Baxter Healthcare Corp. |
| Dec 15, 2015 | XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E.... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottl... | Super-Potent Drug: Out of Specification Assay test results were reported for stability samples. | Class III | Morton Grove Pharmaceuticals, Inc. |
| Dec 15, 2015 | XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Soluti... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | La' Trim Plus Capsules, 350 mg, 60-count bottles, Manufactured for: MWN Heal... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | SLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu ... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N O... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceu... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx... | Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in th... | Class I | Baxter Healthcare Corp. |
| Dec 11, 2015 | FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-c... | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products... | Class I | Reesna, Inc |
| Dec 11, 2015 | FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bo... | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products... | Class I | Reesna, Inc |
| Dec 9, 2015 | Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-... | Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein a... | Class I | Lucy's Weight Loss (dba. Waisted With Lucy) |
| Dec 9, 2015 | Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bo... | Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein a... | Class I | Lucy's Weight Loss (dba. Waisted With Lucy) |
| Dec 8, 2015 | Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Genzyme Corporation |
| Dec 7, 2015 | Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Ba... | Failed Impurities/Degradation Specifications; Impurity A | Class III | Lupin Pharmaceuticals Inc. |
| Dec 3, 2015 | LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Produc... | Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product ... | Class I | Lipo Escultura Corp. |
| Dec 3, 2015 | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 2... | Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the la... | Class II | GlaxoSmithKline, LLC |
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.