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