Browse Drug Recalls

1,749 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,749 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 1,749 FDA drug recalls, Class I.

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DateProductReasonClassFirm
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 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 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 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.
Nov 23, 2015 SUPER HERBS 350 mg, 30 capsules per bottle. Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine ... Class I Super Herbs
Nov 6, 2015 Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol... Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecal... Class I Glades Drugs Inc.
Oct 28, 2015 Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled aut... Defective Delivery System; potential to have inaccurate dosage delivery Class I Sanofi-Aventis U.S. LLC
Oct 28, 2015 Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled au... Defective Delivery System; potential to have inaccurate dosage delivery Class I Sanofi-Aventis U.S. LLC
Oct 5, 2015 NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle... Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. Class I Inaffit, LLC
Oct 1, 2015 Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA. Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie... Class I MSNV, Inc dba National Video Supply
Oct 1, 2015 Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie... Class I MSNV, Inc dba National Video Supply
Sep 30, 2015 Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie... Class I Premiere Sales Group
Sep 30, 2015 Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie... Class I Premiere Sales Group
Sep 29, 2015 Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 o... Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be t... Class I Fit Firm and Fabulous
Sep 25, 2015 ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottl... Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla... Class I Medline Industries Inc
Sep 25, 2015 ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle,... Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla... Class I Medline Industries Inc
Sep 25, 2015 RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and da... Class I Tf Supplements
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.

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.