Losartan Potassium and Hydrochlorothiazide Tablets Recalled Due to AZIDO Impurity Contamination
Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets due to AZIDO impurity levels exceeding acceptable manufacturing standards. The prescription blood pressure medication was distributed nationwide.
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 2/5 (Moderate).
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 II recall for a manufacturing quality issue with detected AZIDO impurity above acceptable regulatory limits. The precautionary recall reflects the CGMP deviation and regulatory limit violation rather than any reported adverse health effects.
Plain-English summary
Macleods Pharma USA Inc is recalling Losartan Potassium and Hydrochlorothiazide tablets (100 mg/12.5 mg) due to Current Good Manufacturing Practice (CGMP) deviations. Testing identified AZIDO impurity levels above acceptable regulatory limits.
The recalled product was distributed nationwide in multiple package sizes: 30-count, 90-count, and 1000-count bottles. Affected lot numbers include BLL2107B (exp. 05/2023), BLL2101A (exp. 01/2025), BLL2102A (exp. 02/2025), BLL2103B (exp. 02/2023), and BLL2104A (exp. 05/2023).
The FDA classified this as a Class II recall. Consumers in possession of affected lots should contact their pharmacy or healthcare provider for guidance regarding their medication.
The recalled product
- Product
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
- Brand
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Antihypertensive
- Hazard
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 (6)
- Lot # BLL2107B
- exp. date 05/2023 BLL2101A
- exp. date 01/2025 BLL2102A
- exp. date 02/2025 BLL2103B
- exp. date 02/2023 BLL2104A
- exp. date 05/2023
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
Same brand · LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
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Same hazard · azido impurity
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Similar recalls
- HighFDA Recalls Losartan-Hydrochlorothiazide Tablets for Manufacturing Quality Deviations
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- SevereMacleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity
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- HighLosartan Potassium and Hydrochlorothiazide tablets recalled for AZIDO impurity
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