Browse Drug Recalls

1,309 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,309 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 1,309 FDA drug recalls in 2014.

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Date	Product	Reason	Class	Firm
Jan 31, 2014	ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oi...	Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t...	Class III	Hill Dermaceuticals, Inc.
Jan 29, 2014	Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: ...	Failed Tablet Specifications: Broken Tablets Present.	Class II	Caraco Pharmaceutical Laboratories Ltd.
Jan 29, 2014	Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E...	Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% ra...	Class III	Fougera Pharmaceuticals Inc.
Jan 29, 2014	GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, ...	Defective Container: Tamper evident ring failures discovered on some bottles.	Class II	Pfizer Inc.
Jan 28, 2014	Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets ...	Failed Impurity/degradation Specification	Class III	Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 28, 2014	Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution...	Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatu...	Class II	RX South LLC DBA RX3 Pharmacy
Jan 28, 2014	Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bott...	Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of...	Class II	Caraco Pharmaceutical Laboratories, Ltd.
Jan 27, 2014	Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstit...	Failed Impurities/Degradation Specifications: Product did not meet specification in total impurit...	Class III	Lupin Pharmaceuticals Inc.
Jan 27, 2014	Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstitute...	Failed Impurities/Degradation Specifications: Product did not meet specification in total impurit...	Class III	Lupin Pharmaceuticals Inc.
Jan 24, 2014	Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Di...	CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved ...	Class II	Teva Pharmaceuticals USA
Jan 24, 2014	Fruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKn...	Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti...	Class I	MyNicNaxs, Inc.
Jan 24, 2014	Meizitang Strong Version Botanical Slimming, Soft Gel Capsules, 650 mg, suppl...	Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti...	Class I	MyNicNaxs, Inc.
Jan 24, 2014	Meizi Evolution Soft Gel Capsules, supplied in 30 count bottles, distributed ...	Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti...	Class I	MyNicNaxs, Inc.
Jan 24, 2014	Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Su...	CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate an...	Class II	Teva Pharmaceuticals USA
Jan 24, 2014	Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cang...	Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti...	Class I	MyNicNaxs, Inc.
Jan 24, 2014	SlimEasy Herbs Capsule, 400 mg, supplied in 30 count boxes, distributed by My...	Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti...	Class I	MyNicNaxs, Inc.
Jan 24, 2014	Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Onl...	CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved...	Class II	Teva Pharmaceuticals USA
Jan 24, 2014	JIANFEIJINDAN Activity Girl Capsules, 400 mg, supplied in 30 count boxes, dis...	Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-d...	Class I	MyNicNaxs, Inc.
Jan 24, 2014	Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Dis...	CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved m...	Class II	Teva Pharmaceuticals USA
Jan 24, 2014	Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distribu...	Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti...	Class I	MyNicNaxs, Inc.
Jan 24, 2014	REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, dist...	Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti...	Class I	MyNicNaxs, Inc.
Jan 24, 2014	Magic Slim capsules, supplied in 60 count bottles, distributed by MyNicKnaxs,...	Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti...	Class I	MyNicNaxs, Inc.
Jan 24, 2014	Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Anoth...	Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti...	Class I	MyNicNaxs, Inc.
Jan 22, 2014	Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per...	Subpotent; 18 month time point	Class II	Fresenius Kabi USA, LLC
Jan 16, 2014	ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent...	Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh...	Class II	The Mentholatum Co.
Jan 16, 2014	ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL...	Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh...	Class II	The Mentholatum Co.
Jan 16, 2014	ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile,...	Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh...	Class II	The Mentholatum Co.
Jan 16, 2014	Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Ma...	Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an A...	Class II	Ranbaxy Inc.
Jan 16, 2014	ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops,...	Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh...	Class II	The Mentholatum Co.
Jan 16, 2014	ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, N...	Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh...	Class II	The Mentholatum Co.
Jan 15, 2014	Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 10...	Failed Tablet/Capsule Specifications; Product contains broken tablets.	Class II	Watson Laboratories Inc
Jan 14, 2014	Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distri...	Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets,...	Class II	Mylan Pharmaceuticals Inc.
Jan 14, 2014	Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For M...	Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that ...	Class II	Traxx International Corp
Jan 13, 2014	Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister...	This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate...	Class III	Merck & Co Inc
Jan 13, 2014	PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distribute...	Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, N...	Class I	HUMAN SCIENCE FOUNDATION
Jan 13, 2014	Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister...	This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate...	Class III	Merck & Co Inc
Jan 13, 2014	Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister...	This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate...	Class III	Merck & Co Inc
Jan 13, 2014	Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister...	Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which c...	Class III	Merck & Co Inc
Jan 10, 2014	Dermamedics Post Procedure Cream, 1 ounce containers which were distributed w...	Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr...	Class II	Dermamedics, L.L.C.
Jan 10, 2014	DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, ...	Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the...	Class I	Hospira Inc.
Jan 10, 2014	Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distribu...	Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr...	Class II	Dermamedics, L.L.C.
Jan 10, 2014	Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post M...	Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr...	Class II	Dermamedics, L.L.C.
Jan 10, 2014	Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SK...	Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr...	Class II	Dermamedics, L.L.C.
Jan 10, 2014	Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml...	Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr...	Class II	Dermamedics, L.L.C.
Jan 10, 2014	Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.	Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr...	Class II	Dermamedics, L.L.C.
Jan 10, 2014	Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml...	Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr...	Class II	Dermamedics, L.L.C.
Jan 10, 2014	Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Las...	Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr...	Class II	Dermamedics, L.L.C.
Jan 10, 2014	Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB1...	Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr...	Class II	Dermamedics, L.L.C.
Jan 9, 2014	SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bay...	Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a...	Class I	Schindele Enterprises dba Midwest Wholesale
Jan 9, 2014	XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.	Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a...	Class I	Schindele Enterprises dba Midwest Wholesale

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.