Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Foreign Plastic Contamination
Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets (50 mg/12.5 mg, lot BLK2304A) due to the presence of a plastic-like foreign substance. The recall affects 1,048 bottles distributed nationwide.
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 involving a foreign object contamination with no reported illnesses or injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).
Plain-English summary
Macleods Pharma USA, Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg, distributed in 1,000-count bottles. The recalled lot is BLK2304A with an expiration date of July 31, 2025 (NDC 33342-050-44).
The tablets have been found to contain a plastic-like foreign substance. This contamination poses a potential safety risk if the tablets are ingested.
The affected bottles were distributed nationwide across the United States. Approximately 1,048 bottles are involved in this recall.
Patients should stop using this medication and contact their healthcare provider or pharmacist. Do not stop taking the medication without consulting a doctor; ask your pharmacy about obtaining unaffected product or an alternative 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
- Hazard
- foreign-object
- contamination
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 (2)
- Lot #: BLK2304A
- Exp. 07/31/2025
UPCs (7)
- 0333342051448
- 0333342050106
- 0333342052100
- 0333342051103
- 0333342052445
- 0333342051073
- 0333342052070
Distribution
Distributed nationwide across the United States.
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