Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Jul 23, 2012	Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters pe...	Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratori...	Class II	American Health Packaging
Jul 18, 2012	Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Ace...	Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free ...	Class II	LNK International, Inc.
Jul 18, 2012	Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & C...	Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary...	Class III	Fougera Pharmaceuticals Inc.
Jul 16, 2012	X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 1...	Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sil...	Class I	Coral Rock Man, Inc.
Jul 13, 2012	CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g...	Microbial Contamination of Non Sterile Product; mold	Class II	Island Kinetics dba Covalence
Jul 12, 2012	Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 m...	Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packagi...	Class III	Axcentria Pharmaceuticals LLC
Jul 9, 2012	Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, R...	cGMP Deviations; does not meet in process specification requirements	Class II	Lloyd Inc. of Iowa
Jul 9, 2012	Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, R...	cGMP Deviations; does not meet in process specification requirements	Class II	Lloyd Inc. of Iowa
Jul 9, 2012	Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, R...	cGMP Deviations; does not meet in process specification requirements	Class II	Lloyd Inc. of Iowa
Jul 9, 2012	Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, R...	cGMP Deviations; does not meet in process specification requirements	Class II	Lloyd Inc. of Iowa
Jul 9, 2012	Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, R...	cGMP Deviations; does not meet in process specification requirements	Class II	Lloyd Inc. of Iowa
Jul 9, 2012	Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, R...	cGMP Deviations; does not meet in process specification requirements	Class II	Lloyd Inc. of Iowa
Jul 6, 2012	NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufact...	Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90...	Class II	Glenmark Generics Inc., USA
Jun 28, 2012	Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 dose...	Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Fact...	Class III	Health Plus Incorporated
Jun 27, 2012	Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplas...	The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, a...	Class II	Hospira Inc.
Jun 18, 2012	Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only...	Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "oi...	Class III	Stat Rx USA
Jun 14, 2012	Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0....	Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufact...	Class II	Dukal Corp.
Jun 5, 2012	Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physi...	Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly...	Class II	Bristol-myers Squibb Company
Jun 5, 2012	Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, M...	Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C ...	Class III	JHP Pharmaceuticals, LLC
Jun 5, 2012	Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physi...	Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly...	Class II	Bristol-myers Squibb Company
May 21, 2012	Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distri...	Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the ...	Class II	Kutol Products Co Inc
May 12, 2012	HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject pr...	Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be...	Class I	Hospira Inc.
Apr 26, 2012	Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. b...	Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on t...	Class III	Bayer Healthcare, LLC
Apr 26, 2012	Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a)...	Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on t...	Class III	Bayer Healthcare, LLC
Apr 21, 2012	X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distri...	Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hyd...	Class I	XRock Industries, LLC
Apr 17, 2012	Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson...	Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used...	Class III	Watson Laboratories Inc
Apr 17, 2012	Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watso...	Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used...	Class III	Watson Laboratories Inc
Apr 17, 2012	Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Wats...	Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used...	Class III	Watson Laboratories Inc
Apr 17, 2012	Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartr...	Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL	Class I	Hospira Inc.
Apr 17, 2012	Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Wats...	Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used...	Class III	Watson Laboratories Inc
Apr 17, 2012	Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle,...	Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used...	Class III	Watson Laboratories Inc
Apr 13, 2012	Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10...	Presence of Particulate Matter: This product is being recalled due to the discovery of particles ...	Class II	West-ward Pharmaceutical Corp.
Apr 13, 2012	Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 m...	Presence of Particulate Matter: This product is being recalled due to the discovery of particles ...	Class II	West-ward Pharmaceutical Corp.
Apr 9, 2012	Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 50...	Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of misl...	Class II	Dr. Reddy's Laboratories, Inc.
Apr 9, 2012	Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By...	Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of misl...	Class II	Dr. Reddy's Laboratories, Inc.
Mar 20, 2012	DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distribut...	Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subp...	Class III	Quadrant Chemical Corporation
Mar 9, 2012	Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX...	Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir ...	Class II	Aurobindo Pharma LTD
Mar 9, 2012	Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufact...	Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is...	Class III	Pack Pharmaceuticals
Feb 24, 2012	Thyro-Tab.075 mg., packaged in bulk drums for repackaging. The firm name on t...	Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.	Class II	Lloyd Inc
Feb 3, 2012	Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on...	Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.	Class II	Lloyd Inc
Oct 17, 2011	Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC indus...	Labeling: Presence of Undeclared Color Additive; The product is being recalled because several in...	Class II	Meda Pharmaceuticals Inc.
Sep 27, 2011	metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate...	Labeling: Label Mix up; product labeled did not indicated Extended Release	Class I	Shamrock Medical Solutions Group LLC
Sep 27, 2011	Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to conta...	Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calc...	Class II	Shamrock Medical Solutions Group LLC
Sep 27, 2011	Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as M...	Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE...	Class I	Shamrock Medical Solutions Group LLC
Sep 27, 2011	Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiam...	Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules	Class I	Shamrock Medical Solutions Group LLC
Sep 27, 2011	Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx...	Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400...	Class II	Shamrock Medical Solutions Group LLC
Sep 27, 2011	Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to cont...	Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexo...	Class II	Shamrock Medical Solutions Group LLC
Jul 5, 2011	Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho...	Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ...	Class II	Noven Pharmaceuticals, Inc.
Jan 19, 2011	METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only...	Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," inste...	Class III	VistaPharm, Inc.
Nov 10, 2010	Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, ...	Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfa...	Class I	Physicians Total Care, 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.