Browse Drug Recalls

207 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 207 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 207 FDA drug recalls in CT.

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DateProductReasonClassFirm
Jan 20, 2026 Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium C... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sa... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, M... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box,... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per c... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towele... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Cu... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 pa... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wi... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme Unit... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette,... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, M... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wi... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.1... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, b... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 p... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelett... CGMP Deviations Class II ACME UNITED CORPORATION
Sep 23, 2025 Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Man... Product Mix-up Class II ACME UNITED CORPORATION
Apr 14, 2025 Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... Class II Breckenridge Pharmaceutical, Inc
Apr 14, 2025 Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, ... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... Class II Breckenridge Pharmaceutical, Inc
Dec 6, 2024 Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (N... CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Breckenridge Pharmaceutical, Inc
Dec 6, 2024 Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (ND... CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Breckenridge Pharmaceutical, Inc
Oct 10, 2024 Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, M... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc
May 17, 2024 Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mf... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc
Apr 29, 2024 Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc
Apr 29, 2024 Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc
Apr 29, 2024 Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, M... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc
Nov 9, 2023 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS U... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag,... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentr... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentrati... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 4... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC

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.