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
Feb 12, 2015 Glycerin 98.5% Opth. Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Sout... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Jan 25, 2015 iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highw... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, m... Class I Detox Transforms
Jan 25, 2015 BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, m... Class I Detox Transforms
Jan 25, 2015 EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein an... Class I Detox Transforms
Jan 25, 2015 iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein an... Class I Detox Transforms
Jan 25, 2015 AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highw... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making... Class I Detox Transforms
Dec 5, 2014 BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactur... Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or ill... Class III Eisai Inc
Oct 10, 2014 Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by ... Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were pac... Class II Contract Packaging Resources Inc.
Jul 30, 2014 Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: S... Presence of Foreign Substance; tablets may contain stainless steel metal particulates Class II Mckesson Packaging Services
Jun 19, 2014 Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. ... Failed Dissolution Specification; at the 12 month time interval. Class III Mckesson Packaging Services
Jun 2, 2014 Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808 Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked i... Class II Unit Dose Solutions Inc
Mar 28, 2014 Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four ... Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso ... Class II United Therapeutics Corp.
Mar 3, 2014 Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets ... Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval. Class III McKesson Packaging Services
Feb 11, 2014 Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactur... Cross Contamination with Other Products: Product contains Promacta (eltrombopag). Class III Viiv Healthcare Company
Nov 6, 2013 Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bot... Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content duri... Class III Sandoz Inc
Nov 6, 2013 Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefill... Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which p... Class II GlaxoSmithKline, LLC.
Nov 6, 2013 Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only... Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which p... Class II GlaxoSmithKline, LLC.
Nov 1, 2013 Idoxuridine 0.1% 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 Gentamycin 80mg/1000cc 0.9% NS 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 Terbutaline/Ipratropium 0.5mg/2.5ml 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 Acetylcysteine 10% 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 Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25% 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 L-Glutathione inhalation 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 Renacidin Irrigation 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 Glutathione 6%/ascorbic 1%/DMSO 6.25% 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 Vitamin D (Ergocalciferol) 800 u/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 AMP/M-B12/Pyridox/Methionine Inositol 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 Vancomycin (fortified) 25mg/ml 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 1% 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 Hydroxocobalamin inj. 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 Testosterone Cypionate 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 Bladder Instillation 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 Prostaglandin all combinations 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 Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg 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 Testosterone Cypionate 200mg/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 Glutathione Inhalation 200mg/5ml 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 phosphate 24mg/ml inj. 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 Lidocaine 4% Urethral Gel 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 Tetracaine 0.5% ophth. 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 Hydroxyprogesterone Caproate 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 Cyano B-12 (Cmpd) 1000mcg/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 Sodium Bicarbonate 8.4% inj. 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 Cyano B-12 p-f 1000mcg/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 Cyanocobalamin 100mcg/ml injection 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 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 Tacrolimus (H20-based) 0.03% ophth. 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 Triamcinolone Acetonide 3mg/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 Folic acid (pf) 10mg/cc inj 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 Vit A (olive oil) 0.1% opth. Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center

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.