CLASS II Drug recall · Reported 26 Nov 2014 · FDA Enforcement Report
Losartan Potassium Tablets USP, 25 mg recalled by Micro Labs Usa, Inc S
Micro Labs Usa, Inc S is recalling Losartan Potassium Tablets USP, 25 mg, distributed in New York. The recall was initiated on 22 Sep 2014 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-0253-2015
- FDA event ID
- 69590
- Recalling firm
- Micro Labs Usa, Inc S, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Sep 2014
- FDA classified
- 18 Nov 2014
- Reported
- 26 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 22 Sep 2014 | Recall initiated by company | |
| 18 Nov 2014 | Classified by FDA | +57 days |
| 26 Nov 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
Product as listed by the FDA
LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10
Where it was distributed
U.S. Including: New York
Questions about this recall
Is Losartan Potassium Tablets USP, 25 mg recalled?
Yes. Micro Labs Usa, Inc S recalled Losartan Potassium Tablets USP, 25 mg on 22 Sep 2014. The recall is Class II and its status is Terminated. Recall number D-0253-2015.
Why was it recalled?
Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
Which lots are affected?
Lot #LJAG003, Expiry: 05/2015
Where was it sold?
U.S. Including: New York
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 21 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 Micro Labs Usa, Inc S
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|---|---|---|---|---|---|
| Drug | CLASS III | Simvastatin Tablets, USP, 80mg recalled by Micro Labs Usa, Inc S | Micro Labs Usa, Inc S | Potency & Assay | Nationwide |
| Drug | CLASS III | Simvastatin Tablets, USP, 20mg a) bottle (42517-0020-10) recalled | Micro Labs Usa, Inc S | Potency & Assay | Nationwide |
| Drug | CLASS III | Simvastatin Tablets, USP, 40mg recalled by Micro Labs Usa, Inc S | Micro Labs Usa, Inc S | Potency & Assay | Nationwide |
| Drug | CLASS III | Simvastatin Tablets, USP, 10 mg recalled by Micro Labs Usa, Inc S | Micro Labs Usa, Inc S | Potency & Assay | NY |
| Drug | CLASS II | Glimepiride Tablets, USP 2 mg, a) recalled by Micro Labs Usa, Inc SGlimepiride | Micro Labs Usa, Inc S | Potency & Assay | 5 states |
Other Losartan recalls
All 64| 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 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 |
| Drug | CLASS II | Losartan Potassium Tablets, USP 25 mg recalled by Strides PharmaLosartan Potassium | Strides Pharma | Potency & Assay | Nationwide |