Browse Drug Recalls

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

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DateProductReasonClassFirm
Jul 30, 2025 Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Elite Stack Reconstitution Solution for Injection, all strengths and presenta... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 pH Buffered Reconstitution Solution for Injection, all strengths and presenta... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, Geno... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LL... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGe... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGeni... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Glutathione Preserved for Injection, all strengths and presentations, GenoGen... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Glutathione Magnesium for Injection, all strengths and presentations, GenoGen... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LL... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 284... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 28... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 28... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 28... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Bacteriostatic Water for Injection, all strengths and presentations, GenoGeni... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentatio... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Calcium Chloride for Injection, all strengths and presentations, GenoGenix, L... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 N... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 N... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL mu... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Magnesium Chloride for Injection, all strengths and presentations, GenoGenix,... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoG... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 N... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Reconstitution XO Solution for Injection, all strengths and presentations, Ge... Lack of Assurance of Sterility Class II GenoGenix LLC
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...

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.