FDA Warning Letters, 483s and Recalls: February 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 |
|---|---|---|---|
| Feb 27, 2026 | Rio Verde Food Service Inc. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Feb 26, 2026 | Longhorn Vaccines And Diagnostics LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Feb 24, 2026 | IsoTis OrthoBiologics, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Feb 24, 2026 | Trangs Group USA Incorporated | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Feb 20, 2026 | 24HrDoc, Inc. Dba 24HrDoc | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Alan Health Technologies Inc. Dba Alan | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Aspen Aesthetics Dba Fifty 410 | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Belle Health LLC Dba Belle | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Better Health Labs, Inc. Dba Measured | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Bliv Wellness LLC Dba Bliv | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | BluefitMD | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Deluxe IV Aesthetics PLLC Dba Deluxe IV And Aesthetics | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Dripgym Mobile Parent, LLC Dba Amp Health | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | FitRX, LLC Dba FitRx | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Genesis Health International Inc. Dba Genesis | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Good Girl LLC Dba GoodGirlRX | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Ivim Services LLC Dba Ivim | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Join Josie | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Kare Solutions, LLC Dba Zappy | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Kin Meds | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Lean Rx, Inc. Dba SkinnyRx | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Levity Inc. Dba Levity | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | MaxLife Technologies Inc. Dba Maxlife | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | MEDVi, LLC Dba MEDVi | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Newman Clinic, PLLC Dba Newman Clinic | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | NewSelf Limited Dba NewSelf | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Peaks Curative, LLC Dba Peaks | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | PharmaZee | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Premium Health Management Inc. Dba Premium Health | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Refills Health, LLC Dba Refills Health | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Strut Health, LLC Dba Strut | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Viv Health, Inc. Dba VIV RX | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Weightless Medical LLC Dba WeightCare | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 20, 2026 | Zeuss LLC Dba Zeuss | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Feb 19, 2026 | El Rey USA Meats & Seafood Inc. | Office of Inspections and Investigations | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Feb 19, 2026 | JMT Inter LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Feb 17, 2026 | Raw Bistro Inc. | Center for Veterinary Medicine | CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Feb 12, 2026 | A. Nelson & Co. Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Feb 12, 2026 | AQ USA Inc., D.B.A Ross Healthcare Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Feb 12, 2026 | Black Sheep Egg Company, LLC | Human Foods Program | PHS Act/Shell Egg Regulation/Adulterated |
| Feb 11, 2026 | Dynamic Stem Cell Therapy | Center for Biologics Evaluation and Research | Unapproved New Drugs/Unlicensed Biological Product Violations |
| Feb 10, 2026 | A TO Z Distributor Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Feb 10, 2026 | Hearthy Foods, Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded |
| Feb 10, 2026 | ProDx Health | Center for Biologics Evaluation and Research (CBER) | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Feb 9, 2026 | Thrive Health And Wellness, LLC Dba Thrive Health Solutions | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products |
| Feb 9, 2026 | VeganicSKN Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Feb 6, 2026 | Cosmetic Manufacturers Pty Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Feb 6, 2026 | ExThera Medical Corporation | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Feb 5, 2026 | Beach Weekend Management LLC Dba Nic And Jet Fuel | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| Feb 5, 2026 | Bio-Medical Pharmaceutical Manufacturing Corporation | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Feb 2, 2026 | Apollo Care, LLC | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products |
| Feb 2, 2026 | Bertrand P. Cole, D.O. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator |
| Feb 2, 2026 | Mark S. Dacey, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator |
| Feb 2, 2026 | Stream2Sea, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
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 |
|---|---|---|---|
| Feb 27, 2026 | Aviva Natural Supplements, LLC | Food/Cosmetics | United States |
| Feb 27, 2026 | Gallant Pet Inc | Veterinary | United States |
| Feb 27, 2026 | Gasco Industrial Corp. | Veterinary | United States |
| Feb 27, 2026 | Reliance Life Sciences Private Limited | Drugs | India |
| Feb 27, 2026 | Tan-Alize Kozmetik Ve Temizlik Urunleri Sanayi Ve Ticaret A.S. | Drugs | Turkey |
| Feb 26, 2026 | Rama Food Manufacture Corp | Food/Cosmetics | United States |
| Feb 26, 2026 | Rama Food Manufacture Corp. | Food/Cosmetics | United States |
| Feb 26, 2026 | Smith & Nephew Wound Management | Drugs | United States |
| Feb 26, 2026 | Zap Expo Center Inc. | Food/Cosmetics | United States |
| Feb 25, 2026 | SCIARRA AEROMED, INC | Veterinary | United States |
| Feb 24, 2026 | Ocho Rios-Miami, Inc. | Food/Cosmetics | United States |
| Feb 23, 2026 | SurgiSmoke Solutions | Devices | United States |
| Feb 20, 2026 | Dreyer's Grand Ice Cream, Inc. | Food/Cosmetics | United States |
| Feb 20, 2026 | Orean Personal Care Ltd | Drugs | United Kingdom |
| Feb 20, 2026 | Staska Pharmaceuticals, Inc. | Drugs | United States |
| Feb 19, 2026 | BOBA FACTORY INC | Food/Cosmetics | United States |
| Feb 19, 2026 | LICO Industries, LLC | Drugs | United States |
| Feb 19, 2026 | T&H Feed Service Inc. | Veterinary | United States |
| Feb 18, 2026 | ISA Produce Corporation | Food/Cosmetics | United States |
| Feb 17, 2026 | Mirac LLC | Devices | United States |
| Feb 13, 2026 | Almon Healthcare Private Limited | Drugs | India |
| Feb 13, 2026 | K.C. Pharmaceuticals, Inc. | Drugs | United States |
| Feb 13, 2026 | Valley Springs Artesian Gold, LLC | Food/Cosmetics | United States |
| Feb 13, 2026 | Woodbine Products Company Inc. | Drugs | United States |
| Feb 12, 2026 | Eaglelionton Int'l Trading Co Inc | Food/Cosmetics | United States |
| Feb 12, 2026 | Nestor Reyes Farm & Associates Inc. | Food/Cosmetics | United States |
| Feb 12, 2026 | Sunset Wholesale West LLC | Tobacco | United States |
| Feb 12, 2026 | Tropical Seas, Inc. | Drugs | United States |
| Feb 10, 2026 | California Dairies, Inc. | Food/Cosmetics | United States |
| Feb 9, 2026 | BioMylz Pvt. Ltd. | Drugs | India |
| Feb 6, 2026 | Auriga Research Private Limited | Drugs | India |
| Feb 6, 2026 | Eugia Pharma Specialities Limited | Drugs | India |
| Feb 5, 2026 | Amigo Mobility International, Inc. | Devices | United States |
| Feb 5, 2026 | Curia New York, Inc. | Drugs | United States |
| Feb 5, 2026 | NexCell Scientific Inc | Biologics | United States |
| Feb 5, 2026 | ONY Biotech, Inc. | Drugs | United States |
| Feb 5, 2026 | Uproar Wellness, LLC | Tobacco | United States |
| Feb 3, 2026 | Iso-Tex Diagnostics, Inc. | Drugs | 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 117.35(a) | Sanitary operations - Plant sanitation | 37 |
| 21 CFR 1.502(a) | Develop FSVP | 24 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 21 |
| 21 CFR 117.35(c) | Pest control | 21 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 20 |
| ISO 13485:2016 Clause 7.1 | Required elements not determined in planning product realization | 20 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 18 |
| 21 CFR 123.6(b) | No HACCP plan | 17 |
| 21 CFR 111.70(e) | Specifications - finished dietary supplement | 15 |
| 21 CFR 211.192 | Written record of investigation incomplete | 15 |
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 |
|---|---|---|---|
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | Medline Industries, LP | Devices | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during… |
| Feb 27, 2026 | PRIMAL SUPPLEMENTS GROUP LLC | Food | FDA laboratory analysis confirmed that Primal Herbs Volume contains sildenafil not listed on the product label. |
| Feb 26, 2026 | Bluegrass Ingredients Inc. | Food | Potential Salmonella contamination |
| Feb 26, 2026 | Bluegrass Ingredients Inc. | Food | Positive Salmonella contamination |
| Feb 26, 2026 | House Of Flavors, Inc. | Food | Undeclared egg |
| Feb 25, 2026 | Dreamland Inc | Food | Undeclared Sesame, Soy, Wheat |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 19, 2026 | Made Fresh Salads Inc | Food | Products may be contaminated with Listeria monocytogenes. |
| Feb 18, 2026 | Abiomed, Inc. | Devices | Increased risk of purge leaks with Generation 1 purge cassettes. |
| Feb 18, 2026 | Baxter Healthcare Corporation | Devices | Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be… |
| Feb 18, 2026 | Navajo Manufacturing Company | Devices | If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be… |
| Feb 16, 2026 | Abiomed, Inc. | Devices | Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first… |
| Feb 13, 2026 | Ambrosia Brands LLC | Food | Product may be contaminated with Salmonella |
| Feb 13, 2026 | Merit Medical Systems, Inc. | Devices | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign… |
| Feb 13, 2026 | Merit Medical Systems, Inc. | Devices | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign… |
| Feb 13, 2026 | Merit Medical Systems, Inc. | Devices | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign… |
| Feb 13, 2026 | Merit Medical Systems, Inc. | Devices | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign… |
| Feb 13, 2026 | Merit Medical Systems, Inc. | Devices | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign… |
| Feb 13, 2026 | Shaman Botanicals, LLC | Food | A sample of the product had the active ingredient in a quantity greater than the labeled specification. |
| Feb 13, 2026 | Shaman Botanicals, LLC | Food | A sample of the product revealed the active ingredient is in a quantity greater than the labeled specification. |
| Feb 12, 2026 | Erbe USA Inc | Devices | Probes may rupture/burst during activation |
| Feb 12, 2026 | Erbe USA Inc | Devices | Probes may rupture/burst during activation |
| Feb 12, 2026 | Erbe USA Inc | Devices | Probes may rupture/burst during activation |
| Feb 12, 2026 | Oregon Potato Company LLC | Food | Listeria monocytogenes |
| Feb 11, 2026 | Juniper Granola, LLC | Food | Products contain undeclared milk and soy. |
| Feb 11, 2026 | Juniper Granola, LLC | Food | Products contain undeclared milk and soy. |
| Feb 8, 2026 | Perfect Pasta, Incorporated | Food | Undeclared shrimp, crab, lobster, pollock (fish), whiting (fish), and soy. |
| Feb 6, 2026 | Trividia Health, Inc. | Devices | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The… |
| Feb 6, 2026 | Trividia Health, Inc. | Devices | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The… |
| Feb 6, 2026 | Trividia Health, Inc. | Devices | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The… |
| Feb 6, 2026 | Trividia Health, Inc. | Devices | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The… |
| Feb 3, 2026 | Prime Food Processing LLC. | Food | Uneviscerated Fish |
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