Blood pressure medication Losartan and hydrochlorothiazide recalled for elevated azido impurity
Direct Rx recalled Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels exceeding acceptable limits. The recall affects 11 bottles distributed in Florida.
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: FDA Class II recall due to manufacturing deviation with impurity contamination exceeding acceptable limits. No illnesses or injuries have been reported in the source material, but the impurity hazard represents a potential risk to patient safety.
Plain-English summary
Direct Rx is recalling Losartan Potassium and Hydrochlorothiazide tablets 100/25 mg due to a manufacturing quality issue involving azido impurity levels exceeding acceptable limits.
The recalled product consists of 11 bottles with lot numbers 08NO2102, 17NO2118, 18NO2123, 25OC2114, and 22NO2105, all with expiration date 1/31/25. Distribution was limited to Florida.
Consumers taking this medication should contact their pharmacist or physician to confirm whether they have received affected tablets and to discuss appropriate alternatives if needed.
The recalled product
- Product
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
- Brand
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Direct Rx
- Category
- Drug — Blood Pressure Medication
- Hazard
- impurity
- manufacturing-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 (5)
- Lots: 08NO2102 Exp. 1/31/25
- 17NO2118 Exp. 1/31/25
- 18NO2123 Exp. 1/31/25
- 25OC2114 Exp. 1/31/25
- 22NO2105 Exp. 1/31/25
Distribution
Distributed in 1 state:
- FL
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