FDA Recalls Hospital Ketamine, Fentanyl, Blood Pressure Drugs Nationwide

The agency said the products were recalled after they were found not to comply with Current Good Manufacturing Practice requirements.

Kelly McBride Ni

Published: 5/1/2026, 5:57:47 PM EDT

FDA Recalls Hospital Ketamine, Fentanyl, Blood Pressure Drugs Nationwide — Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. (Andrew Kelly/Reuters)

A wide range of medications used for pain relief, sedation, and blood pressure support in hospitals and clinical settings have been recalled nationwide after federal regulators said the products failed to meet manufacturing standards.

The recall involves injectable ketamine, fentanyl formulations, and phenylephrine hydrochloride solutions produced by Wells Pharma of Houston LLC, according to the U.S. Food and Drug Administration (FDA).

The affected medications include thousands of ketamine syringes used for anesthesia and sedation, multiple fentanyl products commonly used in hospital pain management and surgical care, and thousands of intravenous bags of phenylephrine, a drug used to treat low blood pressure in critically ill patients. Phenylephrine is often administered to treat hypotension during anesthesia.

The agency said the products were recalled after they were found not to comply with Current Good Manufacturing Practice (CGMP) requirements, which govern how drugs must be produced to ensure their safety, strength, and purity.

The FDA classified the action as a Class II recall, meaning use of the products may cause temporary or medically reversible adverse health effects, though the likelihood of serious harm is considered low.

The FDA said CGMP rules are designed to ensure drugs are consistently manufactured under controlled conditions. "CGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities," the agency states.

Wells Pharma’s recall follows an FDA inspection that identified significant deficiencies in sterile drug production, including inadequate environmental monitoring, aseptic processing issues, and failures in quality control systems, according to an FDA warning letter issued in November 2025.

The letter warned the company that the investigator found “serious deficiencies in your practices for producing drug products, which put patients at risk,” and inspectors observed conditions that could allow contamination in products intended to be sterile.

“Drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health,” stated the letter.

The warning letter also cited failures in labeling, including missing required statements identifying compounded drugs, and inadequate procedures for reporting adverse events.

FDA records show the company had been previously cited in the 2025 inspection that led to the warning letter, as some of the issues were repeat violations despite corrective action plans.

Patients with questions about drugs administered in hospitals and clinical settings should consult a health care professional. The recalled medications are primarily used in controlled clinical settings and are not for outpatient use.