Browse Drug Recalls

855 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 855 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 855 FDA drug recalls in NC.

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DateProductReasonClassFirm
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-coun... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Onl... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-coun... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx O... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Jul 31, 2026 Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organical... Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless st... Class I Liebel-Flarsheim Company LLC
Jul 6, 2026 CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Sing... Lack of Assurance of Sterility Class II Chiesi USA, Inc.
Jun 10, 2026 IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Singl... Lack of assurance of Sterility: Class II ACCORD BIOPHARMA INC
Jun 8, 2026 Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx on... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Apr 7, 2026 Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride... Failed PH Specifications Class III Water-Jel Technologies, LLC
Mar 17, 2026 CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-V... Lack of Assurance of Sterility Class II Chiesi USA, Inc.
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

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.