RecallRadar

FDA Drug recall D-0199-2024

Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, P…

On 2024-01-03 the FDA classified a Class II recall of Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, P… by Cardinal Healthcare, citing CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0199-2024
ClassificationClass II
Statusterminated
Initiated2022-01-26
Published2024-01-03
Last updated2026-09-13 11:52 UTC
CompanyCardinal Healthcare
DistributionUS

Product

Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01

Reason

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Identifiers

code_infoBatch 21000279A, 21000280A

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-0199-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.