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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
Jul 22, 2025 BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chlori... Lack of Assurance of Sterility. Class II Taizhou Kangping Medical Science And Technology...
Jun 30, 2025 Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carto... Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. Class II Cipla USA, Inc.
Jun 16, 2025 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containe... Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal proc... Class II B BRAUN MEDICAL INC
Jun 2, 2025 LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infil... Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... Class II Tailstorm Health INC
Jun 2, 2025 LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single... Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... Class II Tailstorm Health INC
Jun 2, 2025 BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0... Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... Class II Tailstorm Health INC
Jun 2, 2025 KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow I... Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... Class II Tailstorm Health INC
Jun 2, 2025 LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRIN... Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... Class II Tailstorm Health INC
Jun 2, 2025 KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Sl... Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... Class II Tailstorm Health INC
May 28, 2025 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, R... Lack of Assurance of Sterility Class II Apotex Corp.
May 28, 2025 Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. ... Lack of Assurance of Sterility Class II Apotex Corp.
May 28, 2025 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufacture... Lack of Assurance of Sterility Class II Apotex Corp.
May 27, 2025 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fres... Lack of Assurance of Sterility Class II Fresenius Medical Care Holdings, Inc.
May 21, 2025 Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thriv... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions,... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, C... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Cholin... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 8... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inver... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-fi... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions,... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thriv... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Soluti... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thriv... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions,... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverne... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 15, 2025 BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of... Class II CareFusion 213, LLC
May 2, 2025 Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Mult... Lack of Assurance of Sterility Class II Empower Clinic Services, LLC dba Empower Pharmacy
Apr 23, 2025 Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulos... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Pro... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodiu... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromello... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 18, 2025 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Sing... Lack of sterility assurance: Product leakage around the vial neck, which could potentially result... Class II American Regent, Inc.
Apr 18, 2025 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Sing... Lack of sterility assurance: Product leakage around the vial neck, which could potentially result... Class II American Regent, Inc.
Apr 15, 2025 FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0... Lack of Assurance of Sterility Class II Apollo Care, LLC
Apr 2, 2025 Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, M... Lack of assurance of sterility. Bacterial contamination detected in some media fill units Class II Amerisource Health Services LLC
Apr 2, 2025 Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx On... Lack of assurance of sterility. Bacterial contamination detected in some media fill units Class II Amerisource Health Services LLC
Apr 2, 2025 Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx o... Lack of assurance of sterility. Bacterial contamination detected in some media fill units Class II Amerisource Health Services LLC
Mar 31, 2025 PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 31, 2025 Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 31, 2025 Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 31, 2025 dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mc... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 31, 2025 Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 21, 2025 Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manu... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 21, 2025 Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manuf... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 21, 2025 Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Ma... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 21, 2025 Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Via... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 21, 2025 Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manuf... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited

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.