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 |
|---|---|---|---|---|
| Sep 25, 2015 | Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in ... | Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and da... | Class I | Tf Supplements |
| Sep 23, 2015 | Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged ... | Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. | Class I | Lucy's Weight Loss (dba. Waisted With Lucy) |
| Sep 23, 2015 | Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bot... | Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. | Class I | Lucy's Weight Loss (dba. Waisted With Lucy) |
| Sep 23, 2015 | Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-cou... | Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. | Class I | Lucy's Weight Loss (dba. Waisted With Lucy) |
| Aug 27, 2015 | MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The ... | Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphth... | Class I | The One Minute Miracle Inc |
| Aug 27, 2015 | MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules ... | Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosilden... | Class I | The One Minute Miracle Inc |
| Aug 24, 2015 | Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in cont... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged i... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | Thin and Slim Naturally The Natural Alternative AM Dietary Supplement package... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 caps... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 c... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule ... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Sup... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | Xcellerator (product not labeled) | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | TruTrim (product not labeled) | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containe... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 21, 2015 | fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe,... | Subpotent Drug | Class I | Cantrell Drug Company |
| Aug 21, 2015 | fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in... | Subpotent Drug | Class I | Cantrell Drug Company |
| Aug 21, 2015 | fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only... | Subpotent Drug | Class I | Cantrell Drug Company |
| Aug 21, 2015 | fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL s... | Subpotent Drug | Class I | Cantrell Drug Company |
| Aug 21, 2015 | fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), ... | Subpotent Drug | Class I | Cantrell Drug Company |
| Aug 21, 2015 | Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syr... | Subpotent Drug | Class I | Cantrell Drug Company |
| Aug 21, 2015 | fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe,... | Subpotent Drug | Class I | Cantrell Drug Company |
| Aug 17, 2015 | Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 1... | Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to... | Class I | Hartley Medical Center Pharmacy, Incorporated |
| Aug 17, 2015 | Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupi... | Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to... | Class I | Hartley Medical Center Pharmacy, Incorporated |
| Aug 6, 2015 | KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 str... | Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil. | Class I | Blue Square Market, Inc. |
| Aug 6, 2015 | LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged ... | Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein. | Class I | Blue Square Market, Inc. |
| Jul 24, 2015 | ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x... | Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution | Class I | Teva Pharmaceuticals USA |
| Jul 17, 2015 | 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags,... | Presence of Particulate Matter: Customer complaint for an insect found free floating inside a sin... | Class I | Baxter Healthcare Corp. |
| Jul 17, 2015 | 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Si... | Presence of Particulate Matter: Customer complaint for an insect found free floating inside a sin... | Class I | Baxter Healthcare Corp. |
| Jul 17, 2015 | fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free... | Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in s... | Class I | Pharmedium Services, LLC |
| Jul 13, 2015 | Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-coun... | Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desme... | Class I | Life and More LLC |
| Jul 2, 2015 | Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distribute... | Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutr... | Class I | XTREME Z DISTRIBUTORS INC |
| Jun 12, 2015 | PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrit... | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a pres... | Class I | GC Natural Nutrition, Inc. |
| Jun 3, 2015 | Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic ... | Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutra... | Class I | Centro Naturista |
| Jun 3, 2015 | Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic ... | Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutra... | Class I | Centro Naturista |
| May 22, 2015 | Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL... | Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay. | Class I | Pharmedium Services, LLC |
| Apr 28, 2015 | Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct In... | Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone ... | Class I | Teva Pharmaceuticals USA |
| Apr 23, 2015 | Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-... | Presence of Particulate Matter | Class I | Mylan Institutional LLC |
| Apr 23, 2015 | Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL... | Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. | Class I | Hospira Inc. |
| Apr 15, 2015 | Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pai... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... | Class I | Reckitt Benckiser LLC |
| Apr 15, 2015 | Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain ... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... | Class I | Reckitt Benckiser LLC |
| Apr 15, 2015 | Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... | Class I | Reckitt Benckiser LLC |
| Apr 15, 2015 | Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorpha... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... | Class I | Reckitt Benckiser LLC |
| Apr 15, 2015 | Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Ma... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... | Class I | Reckitt Benckiser LLC |
| Apr 15, 2015 | Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... | Class I | Reckitt Benckiser LLC |
| Apr 13, 2015 | HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose In... | Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... | Class I | Pharmedium Services, 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.