Browse Drug Recalls
837 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 837 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 837 FDA drug recalls in NC.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 12, 2025 | Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg,... | Presence of particulate matter: potential presence of metal particulates in the product. | Class II | Merck Sharp & Dohme LLC |
| Dec 12, 2025 | Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Onl... | Presence of particulate matter: potential presence of metal particulates in the product. | Class II | Merck Sharp & Dohme LLC |
| Sep 16, 2025 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, ... | Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the... | Class II | ACCORD HEALTHCARE, INC. |
| Jul 30, 2025 | 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intrave... | Failed Impurities/Degradation Specifications: out of specification results for arsenic in the imp... | Class II | Exela Pharma Sciences LLC |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx On... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx O... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx ... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx ... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Onl... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx O... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Apr 10, 2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, ... | Subpotent | Class II | ACCORD HEALTHCARE, INC. |
| Apr 10, 2025 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, M... | Subpotent | Class II | ACCORD HEALTHCARE, INC. |
| Apr 10, 2025 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, M... | Subpotent | Class II | ACCORD HEALTHCARE, INC. |
| Apr 10, 2025 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, ... | Subpotent | Class II | ACCORD HEALTHCARE, INC. |
| Mar 7, 2025 | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL S... | Lack of Assurance of Sterility | Class II | Exela Pharma Sciences LLC |
| Nov 8, 2024 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx O... | Subpotent drug | Class II | ACCORD HEALTHCARE, INC. |
| Oct 10, 2024 | Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-1... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | ACCORD HEALTHCARE, INC. |
| Oct 10, 2024 | Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | ACCORD HEALTHCARE, INC. |
| Oct 10, 2024 | Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | ACCORD HEALTHCARE, INC. |
| Oct 1, 2024 | Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multip... | Failed Impurities/Degradation Specifications. | Class II | ACCORD HEALTHCARE, INC. |
| Sep 18, 2024 | EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz... | CGMP deviations | Class II | EnviroServe Chemicals Inc. |
| Jun 18, 2024 | Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple do... | Subpotent drug: out of specification results | Class III | Accord Healthcare, Inc. |
| May 17, 2024 | Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, ... | Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*,... | Class III | GlaxoSmithKline LLC |
| Mar 29, 2024 | Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents:... | CGMP Deviations | Class II | HONEYWELL INC |
| Jan 19, 2024 | Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic,... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 d... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Dec 12, 2023 | ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg.... | Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification | Class III | GlaxoSmithKline LLC |
| Nov 9, 2023 | Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C;... | cGMP Deviations | Class II | Family Medical Supply Inc |
| Oct 18, 2023 | Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Si... | Presence of Particulate Matter: Silicone | Class I | Exela Pharma Sciences LLC |
| Oct 18, 2023 | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL S... | Presence of Particulate Matter: Silicone | Class I | Exela Pharma Sciences LLC |
| Oct 18, 2023 | ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 ... | Presence of Particulate Matter: Silicone | Class I | Exela Pharma Sciences LLC |
| Jul 3, 2023 | Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multipl... | Presence of Particulate Matter: Particulate matter identified as fiber. | Class II | Accord Healthcare, Inc. |
| Jul 3, 2023 | Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured... | Presence of Particulate Matter: Particulate matter identified as fiber. | Class II | Accord Healthcare, Inc. |
| Mar 29, 2023 | Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multipl... | Sub-potent drug: assay test result below specifications at 9-month timepoint. | Class III | Accord Healthcare, Inc. |
| Feb 7, 2023 | Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bott... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 1... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Acc... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-1... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, R... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 167... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, 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.