Losartan Potassium Tablets — Class II drug recall D-0974-2022
Terminated recall by Strides Pharma Inc., reported 2022-06-08, distributed nationwide. CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
| Recall number | D-0974-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Strides Pharma Inc., East Brunswick, NJ, United States |
| Recall initiated | 2022-05-18 |
| Classified | 2022-05-28 |
| Reported by FDA | 2022-06-08 |
| Terminated | 2023-10-20 |
| Distributed | Nationwide (US) |
| Quantity | 96,966 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 64380-0933, 64380-0933-04, 64380-0933-05, 64380-0933-08, 64380-0934, 64380-0934-04, 64380-0934-05, 64380-0934-08, 64380-0935, 64380-0935-04, 64380-0935-05, 64380-0935-08 |
| Lot numbers | 64380-935-08, 7900813B, 7900814B, 7900908A, 7900935A, 7900936A, 7900937A, 7900938A, 7900939B, 7901043A, 7901044A, 7901045A, 7901046A, 7901047B, 7901048B, 7901049B, 7901050B, 7901158B, 7901159B, 7901160B, 7901161A, 7901182A, 7901183A, 7901184A, 7901185A, 7901186A, 7901187A, 7901188A, 7901189A, 7901190A, 7901191A, 7901192A, 7901193A, 7901194A, 7901195A, 7901250A, 7901251A, 7901252A, 7901295B, 7901296B and 19 more |
Product
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
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0974-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.