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The Quality Brief

The most recent FDA drug and device enforcement activity. Every new FDA drug and device warning letter and recall, in one place. Subscribe below to get it weekly.

Warning letters (15)

Apr 28, 2026 Drug establishment
Lexia LLC
CGMP/Finished Pharmaceuticals/Adulterated
Apr 28, 2026 Drug establishment
Intas Pharmaceuticals Limited
CGMP/Finished Pharmaceuticals/Adulterated
Apr 28, 2026 Drug establishment
Foshan Miwei Cosmetics Co., Ltd.
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Nov 4, 2025 Drug establishment
Liebel-Flarsheim Company LLC
CGMP/Finished Pharmaceuticals/Adulterated
Nov 4, 2025 Drug establishment
Kath Khemicals LLC
CGMP/Finished Pharmaceuticals/Adulterated
Nov 4, 2025 Drug establishment
Apotex Inc.
CGMP/Finished Pharmaceuticals/Adulterated
Nov 4, 2025 Drug establishment
Scientific Protein Laboratories, LLC
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Oct 28, 2025 Drug establishment
The Tranzonic Companies/Innocore Sales & Marketing Inc.
CGMP/Finished Pharmaceuticals/Adulterated
Oct 28, 2025 Device establishment
Royal Philips
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Oct 28, 2025 Device establishment
Qianjiang Kingphar Medical Material Co Ltd.
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Oct 28, 2025 Device establishment
Contec Medical Systems Co., Ltd.
CGMP/QSR/Medical Devices/Adulterated
Oct 21, 2025 Device establishment
LEVO AG
CGMP/QSR/Medical Devices/Adulterated
Oct 21, 2025 Drug establishment
Melcare Biomedical Pty Ltd
Nonprescription/OTC.”
Oct 21, 2025 Drug establishment
BRS Analytical Services, LLC
CGMP/Finished Pharmaceuticals/Adulterated
Oct 21, 2025 Drug establishment
Acme United Corporation
CGMP/Finished Pharmaceuticals/Adulterated

Recalls (36)

May 12, 2026 Class II
IntegraDose Compounding Services LLC
Subpotent Drug
May 12, 2026 Class II
ANI Pharmaceuticals, Inc.
Defective Container; packets were found to be either empty or partially full.
May 11, 2026 Class II
Haleon US Holdings LLC
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
May 8, 2026 Class II
UCB Biosciences Inc.
Lack of Assurance of Sterility
May 4, 2026 Class III
Sagent Pharmaceuticals
Failed Impurities/Degradation Specifications
May 1, 2026 Class III
Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
May 1, 2026 Class III
Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
May 1, 2026 Class II
Safecor Health, LLC
Presence of a Foreign Substance; black particles observed in liquid
Apr 30, 2026 Class II
Safecor Health, LLC
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Apr 29, 2026 Class II
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Apr 29, 2026 Class II
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Apr 28, 2026 Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the co
Apr 28, 2026 Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
Apr 28, 2026 Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the co
Apr 28, 2026 Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the co
Apr 27, 2026 Class III
Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Apr 27, 2026 Class III
Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Apr 24, 2026 Class II
Lupin Pharmaceuticals Inc.
Presence of particulate matter: a white thread-like structure in the cartridge
Apr 24, 2026 Class I
Wisconsin Pharmacal Company
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Apr 24, 2026 Class III
Lannett Company Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Apr 23, 2026 Class II
Novapproach Spine, LLC
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to
Apr 23, 2026 Class II
C.R. Bard Inc
Due to stain present on the surface of affected foley catheters.
Apr 21, 2026 Class II
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026 Class II
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026 Class II
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026 Class II
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026 Class II
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026 Class II
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026 Class II
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026 Class II
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026 Class II
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Apr 8, 2026 Class II
Becton, Dickinson and Company
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Apr 8, 2026 Class II
Becton, Dickinson and Company
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Apr 8, 2026 Class II
Becton, Dickinson and Company
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Mar 24, 2026 Class II
ICU Medical, Inc.
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in t
Mar 23, 2026 Class II
TANGENT ENDOSCOPY, LLC
Affected devices exhibited fractures at the distal shaft tip without complete detachment.

Warning letters from the FDA warning-letter database; recalls from openFDA enforcement reports. Drug and device only. Each firm links to its FacilityLedger profile where we have one, otherwise to the FDA record.

The Quality Brief

Every new FDA drug and device warning letter and recall, summarized once a week. Free.