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 |
|---|---|---|---|---|
| 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.