Browse Drug Recalls

34 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 34 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 34 FDA drug recalls in 2011.

Date	Product	Reason	Class	Firm
Dec 19, 2011	Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, ...	Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA...	Class I	Body Basics Inc
Dec 2, 2011	Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion O...	A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a s...	Class I	Eagle Pharmaceuticals Inc.
Nov 10, 2011	Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper ra...	Misbranded	Class II	Victus, Inc.
Nov 8, 2011	ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative S...	Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (op...	Class II	Carefusion 213, Llc
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 30, 2011	Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dos...	Defective container; lidding deformity allows the contained product to transpire causing potentia...	Class II	VistaPharm, Inc.
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
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	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	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	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	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 19, 2011	Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 3...	Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-packa...	Class II	Physicians Total Care, Inc.
Jul 6, 2011	Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottl...	Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulos...	Class II	Bausch & Lomb, Inc.
Jul 5, 2011	Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 ho...	Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ...	Class II	Noven Pharmaceuticals, Inc.
Jul 5, 2011	Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 ho...	Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ...	Class II	Noven Pharmaceuticals, Inc.
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.
Jul 5, 2011	Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 ho...	Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ...	Class II	Noven Pharmaceuticals, Inc.
Jun 22, 2011	Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose ...	Lack of Assurance of Sterility	Class II	Nephron Pharmaceuticals Corp.
Jun 15, 2011	Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metere...	CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.	Class III	Apotex Corp.
May 27, 2011	ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750m...	Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.	Class II	A B Nutrition, Inc.
May 27, 2011	PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams P...	Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.	Class II	A B Nutrition, Inc.
May 27, 2011	PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 8...	Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.	Class II	A B Nutrition, Inc.
May 23, 2011	Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: ...	Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tab...	Class III	Physicians Total Care, Inc.
Apr 8, 2011	Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets ...	Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Spe...	Class III	Physicians Total Care, Inc.
Apr 8, 2011	Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets ...	Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Spe...	Class III	Physicians Total Care, Inc.
Apr 8, 2011	Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count table...	Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Spe...	Class III	Physicians Total Care, Inc.
Apr 6, 2011	Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit d...	Defective container; lidding deformity allows the contained product to transpire causing potentia...	Class II	VistaPharm, Inc.
Apr 6, 2011	Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottl...	Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight spe...	Class II	Physicians Total Care, Inc.
Mar 18, 2011	Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Dist...	Impurities/Degradation Products; Product is being recalled due to the potential of not meeting th...	Class II	Physicians Total Care, Inc.
Mar 15, 2011	CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL...	Presence of Particulate Matter: In the course of inspecting retention samples visual particles w...	Class II	Luitpold Pharmaceuticals, Inc.
Feb 10, 2011	Earth Force, Ltd., Power Towels, QS Plus Hand Sanitizing Wipes (antiseptic), ...	Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (782...	Class III	Abc Compounding Company Inc
Feb 8, 2011	Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by B...	Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).	Class III	Physicians Total Care, 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.

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.