Triamterene and Hydrochlorothiazide Capsules Recalled for Failed Quality Specifications
Lannett Company is recalling Triamterene and Hydrochlorothiazide Capsules nationwide because certain lots failed impurity and degradation quality specifications. Consumers taking affected lots should consult their pharmacist or physician.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA classified this as a Class III recall with no reported illnesses or injuries. Failed impurity and degradation specifications represent a quality control issue, not a confirmed harm. Per the rubric, recalls with theoretical hazards and no reported illness are rated no higher than 3, and Class III recalls are typically 1-2.
Plain-English summary
Lannett Company, Inc. is recalling Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only. The recall affects 5,640 bottles distributed nationwide.
The recall was initiated because certain lots failed to meet impurity and degradation quality specifications established by the FDA. The affected lots are 20256318A (manufactured 12/2022), 20256321A (manufactured 12/2022), and 21000238A (manufactured 01/2023).
The product is identified by NDC number 0527-1632-10. Consumers who have this medication should check with their pharmacist or physician to determine if they have one of the affected lots.
Consumers with questions about this recall may contact Lannett Company, Inc. at the address listed in FDA records, or consult with their healthcare provider about appropriate next steps.
The recalled product
- Product
- Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10
- Manufacturer
- Lannett Company Inc.
- Category
- Drug — Prescription Capsules
- Hazard
- impurity
- degradation
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 (3)
- Lots: 20256318A (12/2022)
- 20256321A (12/2022)
- 21000238A (01/2023)
Distribution
Distributed nationwide across the United States.
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