CLASS II ONGOING Drug recall · Reported 15 Apr 2020 · FDA Enforcement Report
Losartan Potassium Tablets, USP 50 mg, Bulk recalled
Teva Pharmaceuticals U is recalling Losartan Potassium Tablets, USP 50 mg, Bulk, distributed in California. The recall was initiated on 25 Mar 2020 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-1101-2020
- FDA event ID
- 85306
- Recalling firm
- Teva Pharmaceuticals U, Parsippany, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Mar 2020
- FDA classified
- 7 Apr 2020
- Reported
- 15 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 25 Mar 2020 | Recall initiated by company | |
| 7 Apr 2020 | Classified by FDA | +13 days |
| 15 Apr 2020 | 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
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00
Where it was distributed
Bulk product was distributed to one re-packager in California.
Questions about this recall
Is Losartan Potassium Tablets, USP 50 mg, Bulk recalled?
Yes. Teva Pharmaceuticals U recalled Losartan Potassium Tablets, USP 50 mg, Bulk on 25 Mar 2020. The recall is Class II and its status is Ongoing. Recall number D-1101-2020.
Why was it recalled?
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Which lots are affected?
Lots 1195625A, 1195624A, 1195623A, exp. date 03/2020
Where was it sold?
Bulk product was distributed to one re-packager in California.
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.
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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 |