Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 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 2,085 FDA drug recalls in 2013.

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Date	Product	Reason	Class	Firm
Mar 11, 2013	Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bo...	Marketed Without an Approved NDA/ANDA: The products are unapproved drugs	Class II	Palmer Natural Products
Mar 11, 2013	Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bot...	Marketed Without an Approved NDA/ANDA: The products are unapproved drugs	Class II	Palmer Natural Products
Mar 11, 2013	NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 coun...	Marketed Without an Approved NDA/ANDA: The products are unapproved drugs	Class II	Palmer Natural Products
Mar 11, 2013	BoostYourGrade.com, Piracetam 390mg Choline 104mg capsules, 250 count bottle,...	Marketed Without an Approved NDA/ANDA: The products are unapproved drugs	Class II	Palmer Natural Products
Mar 11, 2013	Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co.,...	Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the...	Class III	Hi-Tech Pharmacal Co., Inc.
Mar 11, 2013	Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bott...	Marketed Without an Approved NDA/ANDA: The products are unapproved drugs	Class II	Palmer Natural Products
Mar 11, 2013	Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Speci...	Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye i...	Class II	Clinical Specialties Compounding Pharmacy
Mar 11, 2013	Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet ...	Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil whi...	Class I	Green Planet Inc
Mar 11, 2013	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-...	Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel parti...	Class II	Gsms
Mar 7, 2013	4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, ...	Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Mar 7, 2013	Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. t...	Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Mar 7, 2013	Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd...	Subpotent drug: low fill volume in some of the capsules	Class II	Sanofi US
Mar 7, 2013	4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydroc...	Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Mar 7, 2013	4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hy...	Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Mar 7, 2013	Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-...	Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Mar 5, 2013	Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx o...	Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/o...	Class II	Zydus Pharmaceuticals USA Inc
Mar 4, 2013	SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP ...	Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile...	Class II	CareFusion 213, LLC
Mar 4, 2013	Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 S...	Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile...	Class II	CareFusion 213, LLC
Mar 4, 2013	SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators ...	Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile...	Class II	CareFusion 213, LLC
Mar 4, 2013	FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net ...	Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile...	Class II	CareFusion 213, LLC
Mar 4, 2013	SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodiu...	Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile...	Class II	CareFusion 213, LLC
Mar 4, 2013	Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1...	Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile...	Class II	CareFusion 213, LLC
Mar 2, 2013	Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa ...	Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because...	Class III	Physicians Total Care, Inc.
Feb 27, 2013	Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 5...	Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ...	Class III	Mutual Pharmaceutical Company, Inc.
Feb 27, 2013	FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102...	Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ...	Class III	Mutual Pharmaceutical Company, Inc.
Feb 27, 2013	Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mu...	Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ...	Class III	Mutual Pharmaceutical Company, Inc.
Feb 27, 2013	0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, ...	Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injec...	Class II	Baxter Healthcare Corp.
Feb 26, 2013	Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, ...	Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.	Class II	Hospira Inc.
Feb 26, 2013	Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx on...	Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.	Class II	Hospira Inc.
Feb 26, 2013	QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, ...	Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.	Class II	Hospira Inc.
Feb 26, 2013	Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for...	Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identif...	Class III	Mylan Pharmaceuticals Inc.
Feb 26, 2013	Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manu...	Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some caps...	Class II	Sanofi-Synthelabo
Feb 26, 2013	Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0...	Defective Container: This recall is being carried out due to the potential for improperly sealed ...	Class II	Teva Pharmaceuticals USA, Inc.
Feb 26, 2013	Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Flip...	Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.	Class II	Hospira Inc.
Feb 25, 2013	Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient inf...	Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed ...	Class II	Hospira Inc.
Feb 22, 2013	Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Man...	Failed Impurities/Degradation Specifications: This product is being recalled due to an out of spe...	Class III	Lupin Pharmaceuticals Inc.
Feb 22, 2013	Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intraveno...	cGMP Deviation	Class II	Petnet Solution Inc
Feb 19, 2013	Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, No...	Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ...	Class III	Novartis Consumer Health
Feb 19, 2013	Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifun...	Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ...	Class III	Novartis Consumer Health
Feb 19, 2013	Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) T...	Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ...	Class III	Novartis Consumer Health
Feb 19, 2013	Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX onl...	Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ...	Class III	Novartis Consumer Health
Feb 19, 2013	Target Up & Up, athlete's foot cream, full prescription strength, terbinafine...	Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ...	Class III	Novartis Consumer Health
Feb 18, 2013	0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., La...	Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrec...	Class II	Hospira Inc.
Feb 18, 2013	PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorp...	Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.	Class III	L. Perrigo Co.
Feb 15, 2013	Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) ...	Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin ...	Class II	Dr Reddys Laboratories Tennessee LLC
Feb 15, 2013	Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg,...	Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the produ...	Class III	Warner Chilcott Company LLC
Feb 15, 2013	METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira,...	Lack of Assurance of Sterility: There is the potential for the solution to leak from the administ...	Class II	Hospira Inc.
Feb 15, 2013	Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg...	Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the produ...	Class III	Warner Chilcott Company LLC
Feb 15, 2013	Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 ...	Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the produ...	Class III	Warner Chilcott Company LLC
Feb 13, 2013	Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per...	Chemical Contamination: The recall has been initiated based on multiple complaints received from ...	Class III	Glenmark Generics Inc., USA

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.