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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.