Potassium Chloride Extended-Release Tablets USP — Class III drug recall D-1029-2020
Terminated recall by Strides Pharma Science Limited, reported 2020-03-25, distributed nationwide. Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 7
| Recall number | D-1029-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Strides Pharma Science Limited, Bangalore, India |
| Recall initiated | 2020-02-17 |
| Classified | 2020-03-13 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2021-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 2,576 bottles |
| NDC | 64380-0860, 64380-0860-06, 64380-0860-07, 64380-0860-08, 64380-0861, 64380-0861-06, 64380-0861-07, 64380-0861-08 |
| Lot numbers | 7238257A, 7238958A, 7239404A |
| Expiration dates | 2021-07-31, 2021-09-30 |
Product
Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08
Reason for recall
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
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-1029-2020. 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.