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Browse Drug Recalls

6,220 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,220 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 6,220 FDA drug recalls.

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DateProductReasonClassFirm
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
Nov 9, 2023 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 400 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 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 1... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentrati... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentr... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Oct 31, 2023 Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I The Harvard Drug Group LLC dba Major Pharmaceut...
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 F... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL)... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (1... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bo... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I The Harvard Drug Group LLC dba Major Pharmaceut...
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bot... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, ... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 2, 2023 Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Sta... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Co... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, C... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL mult... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx o... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal adminis... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, C... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalm... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 6... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compo... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, R... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL s... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine ... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by ... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Sep 21, 2023 HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx o... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe,... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services 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.