CLASS II ONGOING Drug recall · Reported 22 May 2024 · FDA Enforcement Report
Losartan Potassium and Hydrochlorothiazide Tablets recalled
Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, distributed nationwide in the US. The recall was initiated on 7 May 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0498-2024
- FDA event ID
- 94592
- Recalling firm
- Macleods Pharma USA, Princeton, NJ
- Manufacturer
- Macleods Pharmaceuticals Limited
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 May 2024
- FDA classified
- 15 May 2024
- Reported
- 22 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Foreign Material
- Drug class
- Blood Pressure Medication
Timeline
| 7 May 2024 | Recall initiated by company | |
| 15 May 2024 | Classified by FDA | +8 days |
| 22 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign substance: plastic-like substance.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Presence of foreign substance: plastic-like substance.
Which lots are affected?
Lot #: BLK2304A, Exp. 07/31/2025
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Macleods Pharma USA
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma UsaLevothyroxine Sodium | Macleods Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa | Macleods Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma UsaEszopiclone | Macleods Pharma Usa | Packaging Defects | Nationwide |
| Drug | CLASS II | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium & Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
Other Losartan recalls
All 97| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Losartan Potassium Tablets, USP, 25 mg recalled by Strides PharmaLosartan Potassium | Strides Pharma | Foreign Material | Nationwide |
| Drug | CLASS II | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets, USP 25 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets, USP 100 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets, USP 50 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |