FDA orders recall of antibiotics drug used vs pneumonia, bronchitis, UTI

MANILA, Philippines — The Food and Drug Administration (FDA) has ordered the recall of several batches of a brand of antibiotics used to treat bacterial infections, including pneumonia, bronchitis and urinary tract infection (UTI).

According to FDA Advisory No. 2025-0093 issued on Feb. 5, The Cathay Drug Company Inc. sought the “voluntary recall” of several batches of Triocef oral drops (generic name: Cefixime) because these “did not meet the required product specification based on the chemical assay tests performed by a third-party laboratory, which also concurred with the results of the manufacturer.”

“Based on the submitted test reports, there were inconsistencies in the assay/potency test results,” FDA Director General Dr. Samuel Zacate said in the advisory.

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Inconsistent assay results, according to the United States FDA, can raise doubts about the potency and effectiveness of the drug. These may also be caused by the inaccurate concentration of the drug’s active ingredient, which could lead to overdosing or underdosing.

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Lot numbers

Ordered recalled from the Philippine market were the following lots of Triocef 20 mg/mL granules for suspension with their respective expiry dates: 24A39/January 2026; 24B54/February 2026; 24C43/March 2026; 24E58/May 2026; and 24F66/June 2026.

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Triocef is manufactured by JM Tolmann Laboratories Inc. based in Quezon City while Cathay Drug is the marketing authorization holder.

The antibiotic drug is used to treat acute bronchitis, pneumonia, UTI, gonorrhea, scarlet fever, typhoid fever, sinusitis, tonsilitis and pharyngitis, among other bacterial diseases.

“Therefore, distributors, hospitals, retailers, pharmacies that have the subject product are instructed to discontinue further distribution, sale and use,” the FDA said.

It also advised the public not to use or purchase the specified lots and to report their continuous sale or distribution via email to [email protected]. They may also call the FDA Center for Drug Regulation and Research at (02) 8809-5596.

Any suspected adverse reaction experienced from the use of the products should be reported immediately to the FDA through bit.ly/FDAPHReportSideEffect.