Triamterene and Hydrochlorothiazide Capsules Recalled for Temperature Storage Deviation
Triamterene and Hydrochlorothiazide Capsules (37.5 mg/25 mg) are being recalled nationwide due to temperature exposure during manufacturing that fell outside labeled storage conditions. Affected batches are 21000279A and 21000280A.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a manufacturing deviation that could affect drug quality. No illnesses or injuries have been reported. The hazard is potential loss of drug stability due to improper storage conditions, qualifying as a risk-of-harm product without confirmed injury.
Plain-English summary
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), 100 capsules per bottle, are being recalled nationwide. The product has NDC 0527-1632-01, was manufactured by Cardinal Healthcare, and distributed by Lannett Company, Inc. The recall affects batches 21000279A and 21000280A.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The products were exposed to temperatures outside the labeled storage conditions during the manufacturing process. This temperature deviation could potentially affect the drug's stability and efficacy.
No illnesses or injuries have been reported. Patients currently taking this medication should consult their healthcare provider before continuing use. Pharmacies and healthcare providers should quarantine the affected batches and contact the manufacturer for instructions regarding returns and replacement.
The recalled product
- 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
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug
- Hazard
- temperature-exposure
- storage-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch 21000279A
- 21000280A
Distribution
Distributed nationwide across the United States.
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