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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.