Losartan Potassium and Hydrochlorothiazide Tablets recall
FDA recall D-0498-2024 · initiated May 7, 2024
MACLEODS PHARMA USA, INC recalled Losartan Potassium and Hydrochlorothiazide Tablets in May 2024 — an FDA Class II recall (D-0498-2024) because Presence of foreign substance: plastic-like substance.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of foreign substance: plastic-like substance.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,048 bottles
Details
- Product
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44
- Recalling company
- Macleods Pharms Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- May 7, 2024
- FDA report date
- May 22, 2024
Frequently asked
- Was Losartan Potassium and Hydrochlorothiazide Tablets recalled?
- MACLEODS PHARMA USA, INC recalled Losartan Potassium and Hydrochlorothiazide Tablets in May 2024 — an FDA Class II recall (D-0498-2024) because Presence of foreign substance: plastic-like substance. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Losartan Potassium and Hydrochlorothiazide Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0498-2024 was: Presence of foreign substance: plastic-like substance.
- Is a recalled Losartan Potassium and Hydrochlorothiazide Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Losartan Potassium and Hydrochlorothiazide Tablets are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: BLK2304A, Exp. 07/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0498-2024.