FDA Warning Letters, 483s and Recalls: March 2026
Warning letters
A warning letter is FDA's formal notice that a firm has significant violations. Company names link to the letter on fda.gov. Tobacco retailer letters are counted above but not listed.
| Date | Company | Issuing office | Subject |
|---|---|---|---|
| Mar 31, 2026 | FormPour | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet |
| Mar 31, 2026 | Gram Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet |
| Mar 31, 2026 | Guangzhou Huli Technology Co., Ltd. Dba Fantasy Face | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet |
| Mar 31, 2026 | Lovega LLC Dba Pink Pony Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet |
| Mar 31, 2026 | Mile High Compounds LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet |
| Mar 31, 2026 | PekCura Labs | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet |
| Mar 31, 2026 | Prime Sciences | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet |
| Mar 31, 2026 | Zap Expo Center Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Mar 30, 2026 | DO&CO Aktiengesellschaft/DO&CO, Inc. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
| Mar 30, 2026 | Intas Pharmaceuticals Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 27, 2026 | Baja Fresko Distributors Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Mar 27, 2026 | Ehsan Sadri, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator |
| Mar 27, 2026 | J&B Food Consulting | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Mar 26, 2026 | Eaglelionton Int'l Trading Co Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Mar 26, 2026 | Henan Lvyuan Pharmaceutical Co. Ltd. | Center for Veterinary Medicine | CGMP/API/Adulterated |
| Mar 25, 2026 | Medline Industries, LP | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Mar 23, 2026 | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 20, 2026 | Nupack Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded |
| Mar 20, 2026 | RC Outsourcing, LLC | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products |
| Mar 18, 2026 | Schlechter Farms Inc. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Mar 18, 2026 | Shang Hao Jia, Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Mar 18, 2026 | Yangzhou H&R Plastic Daily Chemical Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 17, 2026 | 4U Health | Center for Biologics Evaluation and Research (CBER) | Premarket Approval/Adulterated |
| Mar 16, 2026 | Microbiological Testing & Consulting, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 13, 2026 | ImmunityBio, Inc. | The Office of Prescription Drug Promotion (OPDP) | False & Misleading Claims/Misbranded |
| Mar 12, 2026 | Adnan Dahdul, MD | Office of Compliance and Biologics Quality | Clinical Investigator/BIMO |
| Mar 12, 2026 | ISA Produce Corporation | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Mar 12, 2026 | Patcos Cosmetics Pvt. Ltd. | Center for Drug Evaluation and Research (CDER) | Finished Drug Products/Adulterated |
| Mar 11, 2026 | Flowchem Pharma Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Mar 11, 2026 | OraLabs, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 9, 2026 | JZ Wholesale, Inc. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Mar 9, 2026 | Vedic Lifesciences Pvt. Ltd. | Center for Drug Evaluation and Research (CDER) | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies |
| Mar 6, 2026 | Espifresh Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Mar 6, 2026 | Half Hill Farm Inc. | Human Foods Program | Unapproved New Drugs/Misbranded |
| Mar 6, 2026 | Middlefield Original Cheese Cooperative | Human Foods Program | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
| Mar 5, 2026 | Life Plus Style Gourmet LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Mar 5, 2026 | Novo Nordisk Inc. | Center for Drug Evaluation and Research (CDER) | Postmarketing Adverse Drug Experience Reporting Requirements |
| Mar 4, 2026 | Citra100Mg | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Mar 3, 2026 | Barcelona Nut Company Inc. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Mar 3, 2026 | Fareva Morton Grove | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 3, 2026 | Ocean Group Inc. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Mar 3, 2026 | Simtra BioPharma Solutions | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 3, 2026 | Tentamus India Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 2, 2026 | NSE Products, Inc. DBA Nu Skin Enterprises, Inc. | Center for Drug Evaluation and Research (CDER) | Electronic Drug Registration and Listing System (eDRLS)/Violations |
OAI inspections
OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after the inspection. Facility names link to the facility's FDA record.
| Date | Facility | Product type | Country |
|---|---|---|---|
| Mar 31, 2026 | IVIMEA LLC | Devices | United States |
| Mar 27, 2026 | Bentley Laboratories LLC | Drugs | United States |
| Mar 27, 2026 | Bushman Organic Farms, Inc. | Veterinary | United States |
| Mar 27, 2026 | Nipro Renal Solutions USA, Corporation | Devices | United States |
| Mar 26, 2026 | Westwood Laboratories, LLC. | Veterinary | United States |
| Mar 20, 2026 | Bausch & Lomb Incorporated | Drugs | United States |
| Mar 20, 2026 | Eosera, Inc. | Drugs | United States |
| Mar 20, 2026 | FILARETOS BROS CO. | Food/Cosmetics | Greece |
| Mar 19, 2026 | Allandale Dairy | Veterinary | United States |
| Mar 19, 2026 | Nanovis LLC | Devices | United States |
| Mar 19, 2026 | PReye LLC | Drugs | United States |
| Mar 19, 2026 | PRIDA IMPORT & EXPORT LLC | Food/Cosmetics | United States |
| Mar 18, 2026 | CABIO Biotech (Wuhan) Co., Ltd. Gedian Branch | Food/Cosmetics | China |
| Mar 18, 2026 | Wilatta Imports LLC | Food/Cosmetics | United States |
| Mar 17, 2026 | Hans Bakery, Inc. | Food/Cosmetics | United States |
| Mar 16, 2026 | Sahara Enterprise Inc. | Food/Cosmetics | United States |
| Mar 13, 2026 | TCI Co., Ltd. - BioCosme PABP BRANCH | Drugs | Taiwan |
| Mar 12, 2026 | GLOBAL IMPORTS ORIGINS | Food/Cosmetics | United States |
| Mar 12, 2026 | Joodrim LLC | Food/Cosmetics | United States |
| Mar 12, 2026 | R2 Digital Milling Technologies Inc. | Devices | United States |
| Mar 11, 2026 | Wilson Livestock | Veterinary | United States |
| Mar 10, 2026 | GERRESHEIMER PEACHTREE CITY LP | Devices | United States |
| Mar 10, 2026 | Old Carolina Farm | Veterinary | United States |
| Mar 10, 2026 | RDM Express Inc. | Food/Cosmetics | United States |
| Mar 10, 2026 | Ship Smart LLC | Food/Cosmetics | United States |
| Mar 9, 2026 | South Asian Food Inc. | Food/Cosmetics | United States |
| Mar 7, 2026 | SI Marketing Inc. | Food/Cosmetics | United States |
| Mar 6, 2026 | Binh Minh Tofu | Food/Cosmetics | United States |
| Mar 6, 2026 | Fresenius USA Manufacturing, Inc. | Drugs | United States |
| Mar 6, 2026 | Linemaster Switch Corporation | Devices | United States |
| Mar 6, 2026 | Pharmaceutics International, Inc. | Drugs | United States |
| Mar 5, 2026 | Sakura Seiki Co., Ltd. Chikuma Factory | Devices | Japan |
| Mar 5, 2026 | Sharp Sterile Manufacturing, LLC | Drugs | United States |
| Mar 5, 2026 | SURETEC INNOVATIONS LLC | Drugs | United States |
| Mar 4, 2026 | Baja Fresko Distributors Inc. | Food/Cosmetics | United States |
Most-cited Form 483 sections
The CFR sections FDA investigators cited most often in inspections that ended this month.
| CFR section | Observation | Citations |
|---|---|---|
| 21 CFR 1.502(a) | FSVP assurances | 61 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 30 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 30 |
| ISO 13485:2016 Clause 7.1 | Required elements not determined in planning product realization | 26 |
| 21 CFR 117.35(c) | Pest control | 24 |
| ISO 13485:2016 Clause 7.4.1 | Supplier performance not monitored | 21 |
| 21 CFR 117.10 | Personnel | 19 |
| 21 CFR 1.506(b) | Supplier verification - follow written procedures | 19 |
| 21 CFR 111.70(b) | Specifications - components | 18 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 18 |
Class I recalls
Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.
| Date | Firm | Product type | Reason |
|---|---|---|---|
| Mar 27, 2026 | North American Rescue LLC. | Devices | Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the… |
| Mar 25, 2026 | Omnicell, Inc. | Devices | Potential for mislabeled syringe produced by the i.v.STATION device. |
| Mar 25, 2026 | Ventec Life Systems, Inc. | Devices | Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended… |
| Mar 24, 2026 | AYCO FARMS INC | Food | Potential Salmonella Contamination |
| Mar 24, 2026 | Medline Industries, LP | Devices | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Mar 24, 2026 | Medline Industries, LP | Devices | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Mar 24, 2026 | Medline Industries, LP | Devices | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Mar 24, 2026 | Medline Industries, LP | Devices | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Mar 24, 2026 | Medline Industries, LP | Devices | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Mar 24, 2026 | Medline Industries, LP | Devices | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Mar 24, 2026 | Medline Industries, LP | Devices | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Mar 24, 2026 | Medline Industries, LP | Devices | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Mar 24, 2026 | Medline Industries, LP | Devices | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Mar 24, 2026 | Medline Industries, LP | Devices | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Mar 24, 2026 | Medline Industries, LP | Devices | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Mar 24, 2026 | Unistel Industries Inc. | Food | Product may be contaminated with Salmonella. |
| Mar 21, 2026 | Buy-Herbal | Drugs | Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine. |
| Mar 19, 2026 | American Contract Systems Inc | Devices | Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose… |
| Mar 19, 2026 | B Braun Medical Inc | Devices | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative… |
| Mar 19, 2026 | B Braun Medical Inc | Devices | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative… |
| Mar 19, 2026 | B Braun Medical Inc | Devices | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative… |
| Mar 19, 2026 | B Braun Medical Inc | Devices | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative… |
| Mar 19, 2026 | B Braun Medical Inc | Devices | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative… |
| Mar 19, 2026 | B Braun Medical Inc | Devices | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative… |
| Mar 19, 2026 | Boston Scientific Corporation | Devices | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac… |
| Mar 19, 2026 | Boston Scientific Corporation | Devices | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac… |
| Mar 18, 2026 | Amneal Pharmaceuticals, LLC | Drugs | Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid… |
| Mar 17, 2026 | Medical Action Industries, Inc. 306 | Devices | Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full… |
| Mar 13, 2026 | AVID Medical, Inc. | Devices | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection… |
| Mar 13, 2026 | AVID Medical, Inc. | Devices | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection… |
| Mar 13, 2026 | AVID Medical, Inc. | Devices | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection… |
| Mar 13, 2026 | AVID Medical, Inc. | Devices | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection… |
| Mar 13, 2026 | AVID Medical, Inc. | Devices | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection… |
| Mar 13, 2026 | AVID Medical, Inc. | Devices | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection… |
| Mar 13, 2026 | AVID Medical, Inc. | Devices | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection… |
| Mar 13, 2026 | AVID Medical, Inc. | Devices | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection… |
| Mar 13, 2026 | AVID Medical, Inc. | Devices | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection… |
| Mar 13, 2026 | AVID Medical, Inc. | Devices | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection… |
| Mar 13, 2026 | Pure Vitamins And Natural Supplements, LLC | Food | FDA analysis revealed the presence of undeclared sildenafil |
| Mar 13, 2026 | Pure Vitamins And Natural Supplements, LLC | Food | FDA analysis revealed the presence of undeclared sildenafil and Tadalafil |
| Mar 13, 2026 | Pure Vitamins And Natural Supplements, LLC | Food | FDA analysis revealed the presence of undeclared sildenafil |
| Mar 12, 2026 | Insulet Corporation | Devices | Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into… |
| Mar 11, 2026 | Griffith Foods Inc. | Food | Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella. |
| Mar 11, 2026 | Griffith Foods Inc. | Food | Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella. |
| Mar 11, 2026 | Griffith Foods Inc. | Food | Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella. |
| Mar 11, 2026 | Intuitive Surgical, Inc. | Devices | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. |
| Mar 11, 2026 | Lone Star Dairy Products LLC | Food | Salmonella spp. identified in finished product testing |
| Mar 10, 2026 | Nuts.Com Inc. | Food | Undeclared Allergen - Wheat and Soy (from Soy Lecithin). The ingredient statement and allergen information do not include wheat or soy. |
| Mar 6, 2026 | Distribuidora De Alimentos Sendero LLC | Food | Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy |
| Mar 6, 2026 | Distribuidora De Alimentos Sendero LLC | Food | Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy |
| Mar 6, 2026 | Kradjian Importing Company, Inc. | Food | Undeclared allergen ingredients (sesame and wheat) in Zaatar Spice mix. |
| Mar 3, 2026 | FRITO-LAY NORTH AMERICA, INC. | Food | Undeclared Allergen: Milk |
| Mar 2, 2026 | Cardinal Health 200, LLC | Drugs | Non-Sterility: microbial contamination identified as Paenibacillus phoenicis |
| Mar 2, 2026 | Philips Respironics, Inc. | Devices | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four… |
| Mar 2, 2026 | Philips Respironics, Inc. | Devices | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four… |
| Mar 2, 2026 | Philips Respironics, Inc. | Devices | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal… |
| Mar 2, 2026 | Philips Respironics, Inc. | Devices | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal… |
| Mar 2, 2026 | Philips Respironics, Inc. | Devices | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four… |
| Mar 2, 2026 | Philips Respironics, Inc. | Devices | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal… |
| Mar 2, 2026 | Philips Respironics, Inc. | Devices | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal… |
| Mar 2, 2026 | Philips Respironics, Inc. | Devices | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four… |
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