Blood Pressure Medication Losartan-HCTZ Recalled for Impurity Deviation
Direct Rx is recalling 81 bottles of Losartan Potassium and Hydrochlorothiazide 100/12.5 mg due to AZIDO impurity exceeding acceptable manufacturing standards. Affected bottles were distributed in Alabama, Georgia, Florida, and Louisiana.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a pharmaceutical product with a manufacturing defect (impurity exceeding acceptable limits) creating potential risk of harm. No illnesses or injuries have been reported in the source material. The hazard is a defined risk without demonstrated patient impact, justifying a High severity classification.
Plain-English summary
Direct Rx is recalling 81 bottles of Losartan Potassium and Hydrochlorothiazide 100/12.5 mg tablets due to CGMP deviations. Testing revealed AZIDO impurity levels above acceptable manufacturing limits. The medication was manufactured by Lupin Pharmaceuticals, Inc. and distributed by Direct Rx.
The affected bottles were distributed in Alabama, Georgia, Florida, and Louisiana. Consumers in these states who have the recalled medication should check their bottles against the affected lot numbers: 11MY2103, 05JA2106, 20MY2115, 22JU2118, 29JY2113, and 13SE2113, which appear in both 30-count (NDC 72189-167-30) and 90-count (NDC 72189-167-90) bottles.
Patients taking this medication should not abruptly discontinue use. Contact your healthcare provider or pharmacist for guidance on next steps, which may include verifying your lot number and obtaining replacement medication if needed.
The recalled product
- Product
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
- Brand
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Direct Rx
- Category
- Drug — Antihypertensive
- Affected units
- 81
Distribution
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