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.

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DateProductReasonClassFirm
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.