Potassium Chloride Extended-Release Tablets — Class II drug recall D-0006-2022
Terminated recall by Strides Pharma Inc., reported 2021-10-20, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0006-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Strides Pharma Inc., East Brunswick, NJ, United States |
| Recall initiated | 2021-09-27 |
| Classified | 2021-10-08 |
| Reported by FDA | 2021-10-20 |
| Terminated | 2022-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,813 bottles |
| Reason classes | specification failure |
| 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 | 7240840A |
| Expiration dates | 2021-12-31 |
Product
Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.
Reason for recall
Failed Dissolution Specifications
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-0006-2022. 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.