CLASS II Drug recall · Reported 8 Jun 2022 · FDA Enforcement Report
Losartan Potassium Tablets, USP, 100 mg recalled by Strides Pharma
Strides Pharma is recalling Losartan Potassium Tablets, USP, 100 mg, distributed nationwide in the US. The recall was initiated on 18 May 2022 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-0974-2022
- FDA event ID
- 90229
- Recalling firm
- Strides Pharma, East Brunswick, NJ
- Brand
- Losartan Potassium
- Manufacturer
- Strides Pharma Science Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 May 2022
- FDA classified
- 28 May 2022
- Reported
- 8 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 18 May 2022 | Recall initiated by company | |
| 28 May 2022 | Classified by FDA | +10 days |
| 8 Jun 2022 | Published in enforcement report | +11 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- AZIDO Impurity levels observed to be above acceptable limits
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08
Where it was distributed
Nationwide
Questions about this recall
Is Losartan Potassium Tablets, USP, 100 mg recalled?
Yes. Strides Pharma recalled Losartan Potassium Tablets, USP, 100 mg on 18 May 2022. The recall is Class II and its status is Terminated. Recall number D-0974-2022.
Why was it recalled?
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Which lots are affected?
64380-935-05 Lots 7901047B, 7901048B, 7901049B & 7901050B, Exp Date Jul-22; Lots 7901185A, 7901186A, 7901187A & 7901188A, Exp Date Oct-22; Lots 7901250A, 7901251A & 7901252A, Exp Date Nov-22. 64380-935-08 Lots 7900813B, 7900814B, 7900908A, 7900935A, 7900936A, 7900937A, 7900938A & 7900939B, Exp Date May-22; Lots 7901043A, 7901044A, 7901045A & 7901046A, Exp Date Jul-22; Lots 7901158B, 7901159B, 7901160B, 7901161A, 7901182A & 7901183A, Exp Date Sep-22; Lots 7901184A, 7901189A, 7901190A, 7901191A, 7901192A, 7901193A, 7901194A & 7901195A, Exp Date Oct-22; Lots 7901295B, 7901296B, 7901297B, 7901298B, 7901299B, 7901300B, 7901301B & 7901302B, Exp Date Nov-22; Lots 7901338A, 7901339A, 7901340A, 7901341A & 7901342A, Exp Date Dec-22; Lot 7901387A, Exp Date Jan-23
Where was it sold?
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 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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|---|---|---|---|---|---|
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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 |