Browse Drug Recalls

2,012 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,012 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 2,012 FDA drug recalls.

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DateProductReasonClassFirm
Mar 18, 2013 Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), R... Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration... Class II West-ward Pharmaceutical Corp.
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 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 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 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 4, 2013 buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carto... Failed Stability Specifications; out of specification results at the 9 month stability time point... Class III American Health Packaging
Feb 1, 2013 CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, R... Labeling: Missing label Class III Fresenius Kabi USA LLC (FK USA)
Feb 1, 2013 TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescripti... Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Fre... Class III Ferring Pharmaceuticals Inc
Jan 28, 2013 Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp.... Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled wit... Class III Stat Rx USA
Jan 23, 2013 Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manuf... Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect ... Class III Mission Pharmacal Co
Dec 28, 2012 Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, M... Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for ... Class I Advance Pharmaceutical Inc
Dec 21, 2012 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 m... Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeli... Class II Lee Pharmaceuticals, Inc
Dec 10, 2012 Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity... Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded ... Class III Upsher Smith Laboratories, Inc.
Dec 7, 2012 Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifen... Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from t... Class III Bayer Healthcare, LLC
Dec 4, 2012 Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per b... Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contain... Class II Abbott Laboratories
Nov 30, 2012 Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, M... Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Regist... Class III West-ward Pharmaceutical Corp.
Nov 19, 2012 EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump ... Defective Container: Pump head detaching from the canister unit upon removal of the overcap. Class III Ascend Therapeutics Inc
Nov 8, 2012 Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor ... Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the wa... Class II Procter & Gamble Co
Nov 8, 2012 Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Steri... Crystallization: Product is being recalled due to visible particulates identified during a retain... Class I Hospira Inc.
Oct 23, 2012 ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxida... Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stabl... Class III Estee Lauder Inc
Oct 15, 2012 AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v)... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... Class III Valeant Pharmaceuticals
Oct 15, 2012 AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g)... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... Class III Valeant Pharmaceuticals
Oct 15, 2012 AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... Class III Valeant Pharmaceuticals
Oct 15, 2012 AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 m... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... Class III Valeant Pharmaceuticals
Oct 15, 2012 AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 ... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... Class III Valeant Pharmaceuticals
Oct 15, 2012 AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... Class III Valeant Pharmaceuticals
Oct 15, 2012 AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid... Class III Valeant Pharmaceuticals
Sep 28, 2012 Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%)... CGMP Deviations: The products were manufactured with raw material which contain unknown particles... Class III ITW Dymon
Sep 27, 2012 CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-co... Short Fill: some bottles contained less than 120-count per labeled claim. Class III Genentech, Inc.
Sep 21, 2012 Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II American Enterprises LLC dba Sterling Gelatin
Sep 4, 2012 Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, ... Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength. Class III Apace KY LLC
Aug 28, 2012 I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, O... Lack of Assurance of Sterility: The product is being recalled because the product label does not ... Class II James G. Cole, Inc.
Aug 28, 2012 Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metere... Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indica... Class II Dispensing Solutions, 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.