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
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
May 25, 2017 CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufa... Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, t... Class I Brian P. Richardson
May 25, 2017 BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx... Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bott... Class I AstraZeneca Pharmaceuticals, LP
May 19, 2017 Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distr... Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product ... Class I DYNAMIC TECHNICAL FORMULATIONS
May 16, 2017 Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewa... Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last... Class I Lupin Limited (Unit 1)
May 5, 2017 GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured... Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA anal... Class I Genetic Edge Compounds LLC
Apr 21, 2017 Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Sing... Presence of Particulate Matter: human hair found within an internal sample syringe. Class I Hospira Inc.
Apr 20, 2017 Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class I C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital... Class I C. O. Truxton
Apr 18, 2017 ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsu... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 ENHANCEROL Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 1... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, ... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 RECTALIS Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplie... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count pa... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, suppl... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied i... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg val... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 co... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, suppli... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 13, 2017 Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HP... Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ... Class I Standard Homeopathic Company
Apr 13, 2017 Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.000000000000... Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ... Class I Standard Homeopathic Company
Mar 28, 2017 LaBri's Body Health Atomic, 60 capsules Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine. Class I Envy Me
Mar 12, 2017 EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for M... Defective Delivery System; reports of the device failing to activate which could result in a pati... Class I Meridian Medical Technologies a Pfizer Company
Mar 12, 2017 EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured ... Defective Delivery System; reports of the device failing to activate which could result in a pati... Class I Meridian Medical Technologies a Pfizer Company
Mar 7, 2017 Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign lang... Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... Class I A&H Focal Inc.
Mar 7, 2017 LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in f... Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... Class I A&H Focal Inc.
Mar 7, 2017 HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign lan... Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... Class I A&H Focal Inc.
Mar 7, 2017 GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign l... Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... Class I A&H Focal Inc.
Mar 7, 2017 LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... Class I A&H Focal Inc.
Mar 7, 2017 Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... Class I A&H Focal Inc.
Mar 7, 2017 YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... Class I A&H Focal Inc.
Mar 7, 2017 DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in ... Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... Class I A&H Focal Inc.
Mar 7, 2017 Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreig... Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... Class I A&H Focal Inc.

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.