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 |
|---|---|---|---|---|
| Mar 21, 2018 | Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne... | Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability... | Class III | Mayne Pharma Inc |
| Feb 26, 2018 | RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured ... | Failed Stability Specifications | Class II | Mckesson Packaging Services |
| Jan 29, 2018 | Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes o... | Subpotent Drug: Out of specification for assay (stability testing) | Class III | Mckesson Packaging Services |
| Nov 9, 2017 | Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distrib... | Failed Dissolution Specifications. | Class II | Mayne Pharma Inc |
| Oct 27, 2017 | Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2m... | Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Cont... | Class I | Fresenius Kabi USA, LLC |
| Sep 11, 2017 | TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg... | CGMP Deviations | Class II | United Therapeutics Corp. |
| Aug 28, 2017 | Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose card... | Failed moisture limits: Out of specification for moisture content. | Class III | Mckesson Packaging Services |
| Jul 21, 2017 | Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in ... | Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil a... | Class I | Chiavna Saffron LLC |
| Jun 15, 2017 | Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-d... | Lack of Sterility Assurance | Class II | Hospira a Pfizer Company |
| Jun 15, 2017 | Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose... | Lack of Sterility Assurance | Class II | Hospira a Pfizer Company |
| Jun 15, 2017 | Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4... | Lack of Sterility Assurance | Class II | Hospira a Pfizer Company |
| Jun 15, 2017 | 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 gr... | Lack of Sterility Assurance | Class II | Hospira a Pfizer Company |
| May 30, 2017 | BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Onl... | Failed Moisture Limits: Product tested out-of-specification for moisture content. | Class III | Mckesson Packaging Services |
| May 16, 2017 | Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metere... | Defective Delivery System: Elevated number of units with out of specification results for leak rate | Class II | GlaxoSmithKline, LLC |
| Mar 22, 2017 | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 20... | Defective Delivery System: Elevated number of units with out of specification results for leak rate. | Class II | GlaxoSmithKline, LLC |
| Feb 23, 2017 | Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 3... | Presence of Foreign Substance: foreign material found in the bulk inventory. | Class II | Mckesson Packaging Services |
| Jan 4, 2017 | Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 ... | Supotent: Out of Specification result for assay test during routine stability testing. | Class III | Mckesson Packaging Services |
| Dec 20, 2016 | Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord... | Failed tablet/capsule specification: missing break line on the 5mg tablet. | Class II | Accord Healthcare, Inc. |
| Nov 13, 2016 | Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, M... | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence ... | Class I | Ultimate Body Tox |
| Sep 15, 2016 | Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carto... | Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no prod... | Class III | Mckesson Packaging Services |
| Sep 8, 2016 | Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cart... | Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but... | Class III | Mckesson Packaging Services |
| Jul 18, 2016 | Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSm... | Penicillin Cross Contamination | Class II | GlaxoSmithKline, LLC |
| Jul 18, 2016 | Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx... | Penicillin Cross Contamination | Class II | GlaxoSmithKline, LLC |
| Jul 18, 2016 | Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmi... | Penicillin Cross Contamination | Class II | GlaxoSmithKline, LLC |
| Jul 18, 2016 | Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoS... | Penicillin Cross Contamination | Class II | GlaxoSmithKline, LLC |
| Apr 12, 2016 | SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC... | Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets. | Class III | Mckesson Packaging Services |
| Jan 5, 2016 | Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and... | Lack of Assurance of Sterility: Failed preservative effectiveness test | Class II | Mayne Pharma Usa |
| Dec 3, 2015 | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 2... | Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the la... | Class II | GlaxoSmithKline, LLC |
| Oct 1, 2015 | Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fen... | Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the... | Class III | Tribute Pharmaceuticals US Inc. |
| Oct 1, 2015 | Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric a... | Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the... | Class III | Tribute Pharmaceuticals US Inc. |
| Aug 14, 2015 | Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contain... | Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin ... | Class II | Merck Sharp & Dohme, Wilson Facility |
| Aug 13, 2015 | Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactur... | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... | Class II | GlaxoSmithKline, LLC. |
| Aug 13, 2015 | Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC ... | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... | Class II | GlaxoSmithKline, LLC. |
| Aug 13, 2015 | Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) ... | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... | Class II | GlaxoSmithKline, LLC. |
| Aug 13, 2015 | Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by... | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... | Class II | GlaxoSmithKline, LLC. |
| Jul 2, 2015 | CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged... | Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops. | Class III | Bestco, Inc. |
| Feb 12, 2015 | EDTA 3% Eye Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, ... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
| Feb 12, 2015 | Laureth-P 1% Injection (Polidocanol), Health Innov Pharmacy, 295 Pinehurst Av... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
| Feb 12, 2015 | Hydroxyurea 100 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, South... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
| Feb 12, 2015 | Dexamethasone 4 mg/mL Iontophoresis, Health Innov Pharmacy, 295 Pinehurst Ave... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
| Feb 12, 2015 | Nexium 2 mg/1 mL Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
| Feb 12, 2015 | Folic Acid 2 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
| Feb 12, 2015 | Voriconazole 1% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Souther... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
| Feb 12, 2015 | Thymol 2% Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
| Feb 12, 2015 | Coconut Oil Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern P... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
| Feb 12, 2015 | Fortified Vancomycin 25 mg/1 mL Opth Drops, Health Innov Pharmacy, 295 Pinehu... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
| Feb 12, 2015 | Levodopa 250 mg NSR Capsules,Health Innov Pharmacy, 295 Pinehurst Ave, Southe... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
| Feb 12, 2015 | HCG 1000 Units/mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southe... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
| Feb 12, 2015 | Testosterone 100 mg/1 mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave,... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
| Feb 12, 2015 | Nystatin 50,000 Units Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, ... | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... | Class II | Health Innovations Pharmacy, Inc |
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.