Losartan Potassium tablets recalled for excessive AZIDO impurity
Strides Pharma is recalling approximately 200,407 bottles of Losartan Potassium 25 mg tablets nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits.
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: FDA Class II recall with no reported illnesses or injuries. The manufacturing quality deviation involves an impurity above acceptable limits, classified as low-risk contamination requiring precautionary recall action.
Plain-English summary
Strides Pharma Inc. is recalling Losartan Potassium Tablets, USP 25 mg due to Current Good Manufacturing Practice (CGMP) deviations. Testing revealed that AZIDO impurity levels in certain manufactured lots exceeded acceptable limits.
The recall affects approximately 200,407 bottles distributed nationwide. Multiple lots are involved with expiration dates ranging from June 2022 through December 2022. Affected lots include NDC 64380-933-05 (Lots 7901007A, 7901144A, 7901178A, 7901179A, 7901246A, 7901247A, 7901343A) and NDC 64380-933-08 (Lots 7901006A, 7901145A, 7901180A, 7901181A) with various expiration dates as specified by the manufacturer.
Consumers and patients should not discontinue their medication without consulting a healthcare provider. Those with affected bottles should contact their pharmacy or physician for guidance on alternative supplies or verification of their current medication.
The recalled product
- Product
- LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
- Brand
- LOSARTAN POTASSIUM
- Manufacturer
- Strides Pharma Inc.
- Category
- Drug
- Hazard
- Affected units
- 200,407
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 (12)
- NDC 64380-933-05 Lot 7901007A
- Exp Date Jun-22
- Lot 7901144A
- 7901178A & 7901179A
- Exp Date Sep-22
- Lots 7901246A & 7901247A
- Exp Date Oct-22
- Lot 7901343A
- Exp Date Dec-22. NDC 64380-933-08 Lot 7901006A
- Lot 7901145A & 7901180A
- Lot 7901181A
- Exp Date Oct-22.
UPCs (9)
- 0364380933052
- 0364380935056
- 0364380935087
- 0364380935049
- 0364380934042
- 0364380933045
- 0364380934080
- 0364380933083
- 0364380934059
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Strides Pharma 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 3 products in this recall →Related recalls
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