Losartan Potassium Tablets Recalled for Elevated AZIDO Impurity Levels
Strides Pharma Inc. is recalling Losartan Potassium 50 mg tablets distributed nationwide due to AZIDO impurity levels exceeding acceptable FDA manufacturing standards.
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 an FDA Class II drug recall with no reported illnesses, injuries, or hospitalizations. The hazard—manufacturing contamination with elevated AZIDO impurity levels—represents a potential risk of harm, but no adverse effects have been documented. Per the rubric, risk-of-harm products without reported injury receive a High (3) severity rating.
Plain-English summary
Strides Pharma Inc. is recalling specific batches of Losartan Potassium Tablets, USP, 50 mg (Rx Only), due to Current Good Manufacturing Practice (CGMP) deviations. Testing identified AZIDO impurity levels in affected batches that exceeded acceptable limits established by FDA standards.
The recalled product was manufactured by Vivimed Life Sciences Private Limited (India) and distributed nationwide by Strides Pharma Inc. Affected batches include multiple lot numbers with expiration dates ranging from June 2022 through January 2023. Approximately 381,456 bottles are involved in this recall.
Patients currently taking affected batches should not stop taking their medication without consulting a healthcare provider, as abrupt discontinuation of blood pressure medication can be harmful. Patients should contact their pharmacy or healthcare provider to determine if they have received affected product and to discuss appropriate next steps. Healthcare providers and pharmacies should quarantine affected product and return it to their wholesaler or contact Strides Pharma Inc. directly.
The recalled product
- Product
- LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
- Brand
- LOSARTAN POTASSIUM
- Manufacturer
- Strides Pharma Inc.
- Category
- Drug — Antihypertensive
- Affected units
- 381,456
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 (20)
- NDC 64380-934-05 Lot 7901146A
- 7901147A
- 7901148A & 7901149A
- Exp Date Sep-22
- Lot 7901279A
- 7901280A
- 7901281A
- 7901282A
- 7901283A & 7901284A
- Exp Date Nov-22
- Lot 7901359A
- 7901360A & 7901361A
- Exp Date Dec-22
- Lot 7901362A
- 7901406A
- 7901407A
- 7901408A & 7901409A
- Exp Date Jan-23. 64380-934-08 Lot 7901008A & 7901009A
- Exp Date Jun-22
- Lot 7901150A & 7901151A
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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