RecallRadar

FDA Drug recall D-0877-2018

Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morga…

On 2018-06-20 the FDA classified a Class III recall of Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morga… by Mylan Pharmaceuticals, citing superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0877-2018
ClassificationClass III
Statusterminated
Initiated2018-06-07
Published2018-06-20
Last updated2026-09-13 11:52 UTC
CompanyMylan Pharmaceuticals
DistributionUS

Product

Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01

Reason

Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.

Identifiers

code_infoLot #: 3087136, Exp 5/20

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0877-2018%22

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