The Recall Desk
ModerateFDA (Drugs)·D-0161-2023·Announced 2023-01-25

Triamterene and Hydrochlorothiazide Capsules Recalled for Failed Quality Specifications

Lannett Company is recalling Triamterene and Hydrochlorothiazide Capsules nationwide because the medication failed quality testing for impurity and degradation specifications. The recall affects 20,040 bottles.

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: This is an FDA Class III drug recall initiated for manufacturing quality control failure. No illnesses, injuries, or deaths have been reported. The recall is precautionary in nature, based on failed specifications rather than known harm.

Plain-English summary

Lannett Company Inc. is recalling Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), distributed nationwide in the United States. The recall affects approximately 20,040 bottles in sizes of 100 or 1,000 capsules per bottle.

The recall was initiated because these lots failed quality specifications for impurity and degradation testing, which are required to ensure the safety and efficacy of the medication.

The affected lot codes are 21000279A (expiration date 01/2023) and 20256320A (expiration date 12/2022). The product is identified by National Drug Code (NDC) numbers 0527-1632-01 for 100-count bottles and 0527-1632-10 for 1,000-count bottles.

The recalled product

Product
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10
Manufacturer
Lannett Company Inc.
Category
Drug
Hazard
Affected units
20,040

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)

  • Lots: 21000279A (exp 01/2023)
  • 20256320A (12/2022)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Lannett Company Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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