Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Manufacturing Defect
Macleods Pharma USA Inc is recalling multiple lots of Losartan Potassium and Hydrochlorothiazide tablets (NDC# 33342-052-07, 33342-052-10, 33342-052-44) distributed nationwide due to AZIDO impurity levels exceeding acceptable limits.
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 with no reported hospitalizations, illnesses, or injuries, meeting the criteria for High severity as a risk-of-harm product where injury has not yet been reported. The manufacturing quality defect involves chemical impurities above acceptable limits, which warrants recall despite the absence of current adverse event reports.
Plain-English summary
Macleods Pharma USA Inc is recalling multiple lots of Losartan Potassium and Hydrochlorothiazide (HCTZ) tablets, 100 mg/25 mg. The affected lots—BLM2106B, BLM2101A, BLM2102A, BLM2106A, BLM2103B, BLM2104A, and BLM2110A—were distributed nationwide in 30-count, 90-count, and 1,000-count bottles (NDC# 33342-052-07, 33342-052-10, and 33342-052-44).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Testing found AZIDO impurity levels in affected lots that exceed acceptable manufacturing limits. AZIDO is a controlled chemical impurity in pharmaceutical manufacturing that must be maintained within established safety parameters.
Patients taking affected lots of this blood pressure medication should verify their medication's lot number and expiration date against the affected lots listed above. Any questions should be directed to the pharmacy or healthcare provider.
The recalled product
- Product
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
- Brand
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Blood Pressure Medication
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 (8)
- Lot # BLM2106B
- exp. date 05/2023 BLM2101A
- exp. date 01/2025 BLM2102A
- exp. date 02/2023 BLM2106A
- exp. date 05/2023 BLM2103B
- exp. date 02/2023 BLM2104A
- exp. date 05/2023 BLM2110A
- exp. date 06/2023
UPCs (7)
- 0333342051448
- 0333342050106
- 0333342052100
- 0333342051103
- 0333342052445
- 0333342051073
- 0333342052070
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Macleods Pharma Usa 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 6 products in this recall →Related recalls
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