Browse Drug Recalls

838 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 838 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 838 FDA drug recalls in NC.

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DateProductReasonClassFirm
Nov 1, 2013 Tacrolimus 0.02% opth. (H20-based) Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 Methotrexate Intraocular 400mcg 0.1cc Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 Voriconazole 0.5mg/ml Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 Bleomycin Sulfate 1unit/ml Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 EDTA 3% ophthalmic Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 Novarel (IM) Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 Dexamethasone (pf) 0.05 % opth. Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 Ethanol 20% ophthal. Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 Papaverine 12mg/phent 1mg/Pros 9mcq/ml Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 Methylcobalamin Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 Pyridoxine (p-f) 100mg/ml Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 Scopolamine 0.25 opth. Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 5-Fluorouracil pf in methocel 1% opthal Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Nov 1, 2013 Papaverine 1nj 30mg/ml Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Oct 18, 2013 Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compo... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 18, 2013 Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr B... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 18, 2013 Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Su... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 18, 2013 PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compou... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 18, 2013 Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 260... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 11, 2013 Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 10... Subpotent; Hydrochlorothiazide at the 9 month time point. Class II Sandoz Inc
Sep 6, 2013 Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, ... Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (fro... Class II Triangle Compounding
Sep 6, 2013 Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL ... Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (fro... Class II Triangle Compounding
Aug 6, 2013 REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple... Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the ... Class II Showline Automotive Products, Inc. dba US Soaps...
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.
Jan 10, 2013 Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hosp... Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial Class II Hospira, Inc.
Oct 24, 2012 Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 m... Product Lacks Stability: These lots are being recalled due to the failure to meet the particle si... Class III GlaxoSmithKline, LLC.
Oct 24, 2012 Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation A... Product Lacks Stability: These lots are being recalled due to the failure to meet the particle si... Class III GlaxoSmithKline, LLC.
Oct 8, 2012 Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusio... Impurities/Degradation Products: Potential for drug related impurities to exceed the specificatio... Class II GlaxoSmithKline, LLC.
Aug 14, 2012 Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate... Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... Class III Actavis Mid Atlantic LLC
Aug 14, 2012 Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phen... Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... Class III Actavis Mid Atlantic LLC
Jul 26, 2012 Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200... Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specificat... Class II GlaxoSmithKline Inc
Jul 23, 2012 Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #:... Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride b... Class II Custom Medical Specialties, Inc.
Jul 23, 2012 CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 m... Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride b... Class II Custom Medical Specialties, Inc.
Jul 23, 2012 CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chlor... Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride b... Class II Custom Medical Specialties, Inc.
Jun 4, 2012 Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 6... Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrec... Class II GlaxoSmithKline Inc
Mar 29, 2012 buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets... Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... Class III McKesson Packaging Services
Mar 29, 2012 buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets... Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... Class III McKesson Packaging Services

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.