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
Dec 20, 2013	CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povid...	Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nai...	Class II	Carefusion 2200 Inc
Dec 20, 2013	CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povido...	Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nai...	Class II	Carefusion 2200 Inc
Dec 9, 2013	Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (ND...	Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial...	Class II	Actavis Inc
Nov 27, 2013	0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Bra...	Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 ...	Class II	B. Braun Medical Inc
Nov 18, 2013	Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Dis...	Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary ...	Class I	SS Wholesale Inc. dba Jobbers Wholesale
Nov 8, 2013	PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple ...	Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinica...	Class III	Fresenius Kabi USA, LLC
Nov 6, 2013	Carbon Dioxide, USP, Medical Gas, Rx only, Non Flammable Gas 2, in 50 lbs ste...	Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in...	Class II	Airgas Medical Services
Nov 5, 2013	sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Dist...	Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36...	Class II	Greenstone LLC
Nov 1, 2013	Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, ...	Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Exten...	Class II	Greenstone Llc
Oct 31, 2013	Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fres...	Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial...	Class II	Fresenius Kabi USA, LLC
Oct 21, 2013	Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For ...	Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was fo...	Class I	Medisca Inc.
Oct 19, 2013	Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx o...	Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar...	Class II	Specialty Medicine Compounding Pharmacy
Oct 11, 2013	Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose ...	Presence of Precipitate; precipitation of drug product	Class II	Teva Pharmaceuticals USA
Oct 2, 2013	Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blist...	Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mE...	Class III	Cardinal Health
Sep 23, 2013	Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single D...	Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to d...	Class II	West-Ward Pharmaceutical Corp.
Sep 23, 2013	Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Do...	Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to d...	Class II	West-Ward Pharmaceutical Corp.
Sep 20, 2013	Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt...	Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an in...	Class III	Valeant Pharmaceuticals North Am
Sep 13, 2013	Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bott...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Pharmaceuticals Inc.
Sep 6, 2013	Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottl...	Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact ...	Class I	Altaire Pharmaceuticals, Inc.
Sep 3, 2013	Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufac...	Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken t...	Class III	Novartis Consumer Health
Aug 29, 2013	IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05)...	Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an inco...	Class II	Dr. Reddy's Laboratories, Inc.
Aug 17, 2013	Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amne...	Failed dissolution specifications; 18 month CRT	Class II	Amneal Pharmaceuticals of New York, LLC.
Aug 8, 2013	EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg),...	LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 co...	Class II	Qualitest Pharmaceuticals
Aug 8, 2013	K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium...	LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 co...	Class II	Qualitest Pharmaceuticals
Aug 6, 2013	Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and algi...	Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Aug 6, 2013	Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicon...	Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Aug 6, 2013	Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, W...	Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Aug 6, 2013	Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg...	Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Aug 6, 2013	Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and algi...	Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Aug 6, 2013	Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg,...	Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Aug 6, 2013	Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and sim...	Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Aug 6, 2013	Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicon...	Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Aug 6, 2013	Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and sim...	Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ...	Class III	Novartis Consumer Health
Aug 1, 2013	Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by ...	Labeling: Incorrect Package Insert; product packaged with outdated version of the insert	Class III	AbbVie Inc.
Jul 31, 2013	B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, ...	Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclare...	Class I	Healthy Life Chemistry Inc dba Purity First
Jul 31, 2013	Multi-Mineral capsules, 200-count bottles, labeled in part as Healthy Life Ch...	Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this produ...	Class I	Healthy Life Chemistry Inc dba Purity First
Jul 25, 2013	Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL...	Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes lab...	Class III	Hi-Tech Pharmacal Co., Inc.
Jul 23, 2013	Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactur...	Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (H...	Class II	Teva Pharmaceuticals USA, Inc.
Jul 18, 2013	TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 C...	Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable...	Class III	GlaxoSmithKline, LLC.
Jul 2, 2013	FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, ...	Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PH...	Class II	Aidapak Services, LLC
Jul 2, 2013	FLUCONAZOLE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, N...	Labeling: Label Mixup: FLUCONAZOLE, Tablet, 200 mg may have potentially been mislabeled as one of...	Class II	Aidapak Services, LLC
Jul 2, 2013	VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, Over The Counter, Distributed by...	Labeling:Label Mixup; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet may be potentially mislabeled a...	Class II	Aidapak Services, LLC
Jul 2, 2013	COENZYME Q-10, Capsule 100 mg, Over The Counter, Distributed by: AidaPak Serv...	Labeling: Label Mixup; COENZYME Q-10 Capsule, 100 mg may be potentially mislabeled as ASPIRIN ...	Class II	Aidapak Services, LLC
Jul 2, 2013	PERPHENAZINE, Tablet, 8 mg, Rx only, Distributed by: AidaPak Service, LLC, ND...	Labeling: Label Mixup: PERPHENAZINE, Tablet, 8 mg may have potentially been mislabeled as the fol...	Class II	Aidapak Services, LLC
Jul 2, 2013	NIFEDIPINE Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC...	Labeling: Label Mixup; NIFEDIPINE Capsule, 10 mg may be potentially mislabeled as MULTIVITAMI...	Class II	Aidapak Services, LLC
Jul 2, 2013	SILDENAFIL CITRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, ...	Labeling: Label Mixup: SILDENAFIL CITRATE, Tablet, 25 mg may have potentially been mislabeled as ...	Class II	Aidapak Services, LLC
Jul 2, 2013	FLECAINIDE ACETATE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service,...	Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the fo...	Class II	Aidapak Services, LLC
Jul 2, 2013	guaiFENesin ER, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC...	Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROS...	Class II	Aidapak Services, LLC
Jul 2, 2013	carBAMazepine ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LL...	Labeling: Label Mixup; carBAMazepine ER Tablet, 200 mg may be potentially mislabeled as ACARBO...	Class II	Aidapak Services, LLC
Jul 2, 2013	glyBURIDE MICRONIZED, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service,...	Labeling: Label Mixup: glyBURIDE MICRONIZED, Tablet, 3 mg may have potentially been mislabeled as...	Class II	Aidapak Services, LLC

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.