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
Mar 15, 2018 All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Co... Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange... Class I Bayer HealthCare Pharmaceuticals, Inc.
Mar 8, 2018 Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pa... Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tada... Class I Jimmy Weber
Feb 14, 2018 Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural ... Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence... Class I Bella All Natural
Feb 7, 2018 Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... Class I Pfizer Inc.
Feb 7, 2018 Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... Class I Pfizer Inc.
Jan 26, 2018 Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured ... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 26, 2018 Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured ... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 26, 2018 Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules,... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 26, 2018 Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules,... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 17, 2018 Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured ... Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative conta... Class I Magno Humphries Laboratories, Inc
Jan 12, 2018 HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial,... Non-Sterility Class I The Compounding Pharmacy of America
Jan 12, 2018 Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-U... Presence of Particulate Matter; contains visible particulate matter identified as mold. Class I AuroMedics Pharma LLC
Jan 5, 2018 MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (US... Subpotent Class I Advanced Pharma Inc.
Jan 4, 2018 Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: In... LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogr... Class I International Laboratories, LLC
Jan 2, 2018 Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for in... Presence of Particulate Matter: A confirmed customer report was received for the presence of visi... Class I Aurobindo Pharma Ltd.
Dec 20, 2017 Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use ... Presence of Particulate Matter; white particulate matter identified as mold was found in one bag Class I AuroMedics Pharma LLC
Dec 7, 2017 BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-cou... Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibut... Class I BotanicalNow
Dec 4, 2017 Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only,... Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) ... Class I AuroMedics Pharma LLC
Nov 29, 2017 BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long B... Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sil... Class I Blue Fusion Natural
Nov 19, 2017 Hard Times For Men capsules, packaged in a 23-count box of blister packs cont... Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredie... Class I www.blankterrmall.com
Nov 10, 2017 Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx O... Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of... Class I Baxter Healthcare Corporation
Nov 9, 2017 GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118... Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans Class I Kareway Products Inc
Oct 27, 2017 Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2m... Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Cont... Class I Fresenius Kabi USA, LLC
Oct 20, 2017 diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 m... SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent Class I Pfizer Inc.
Sep 20, 2017 Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-s... Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil. Class I Natures Supplement
Sep 15, 2017 grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana See... Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... Class I Gadget Island, Inc
Sep 15, 2017 FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, ... Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... Class I Gadget Island, Inc
Sep 15, 2017 Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by... Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which i... Class I Baxter Healthcare Corporation
Sep 15, 2017 PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distribute... Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... Class I Gadget Island, Inc
Sep 15, 2017 RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packet... Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... Class I Gadget Island, Inc
Sep 5, 2017 Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with... Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials. Class I Genentech, Inc.
Aug 30, 2017 Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only... Presence of Particulate Matter: glass particulate found in vial Class I Pfizer Inc.
Aug 29, 2017 PIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, ... Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone. Class I Lucky Mart Inc.
Aug 7, 2017 Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged fo... Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with B... Class I International Laboratories, Inc.
Aug 3, 2017 Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured... Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing. Class I Amneal Pharmaceuticals of New York, LLC
Aug 1, 2017 NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count p... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared silde... Class I The Ampt Life, LLC
Jul 24, 2017 LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by L... Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: product... Class I EZWeightLossTX LLC
Jul 24, 2017 LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by La... Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: product... Class I EZWeightLossTX LLC
Jul 21, 2017 Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in ... Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil a... Class I Chiavna Saffron LLC
Jul 17, 2017 New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red pac... Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclar... Class I BESTHERBS COFFEE LLC
Jul 5, 2017 D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore For... Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. Class I HARDCORE FORMULATIONS
Jul 5, 2017 ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcor... Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. Class I HARDCORE FORMULATIONS
Jun 22, 2017 MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop... Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sild... Class I Vitility
Jun 9, 2017 NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m... Subpotent Drug: found to be below the specification for labeled assay. Class I Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1... Subpotent Drug: found to be below the specification for labeled assay. Class I Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10... Subpotent Drug: found to be below the specification for labeled assay. Class I Advanced Pharma Inc.
Jun 6, 2017 ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsu... Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. Class I Andropharm, LLC
Jun 6, 2017 ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and... Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. Class I Andropharm, LLC
Jun 5, 2017 EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squ... Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eli... Class I Bristol-myers Squibb Company
May 31, 2017 Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manuf... Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stab... Class I Teva Pharmaceuticals

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.