Nitrofurantoin Capsules — Class II drug recall D-0597-2024
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2024-07-24, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0597-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2024-07-09 |
| Classified | 2024-07-12 |
| Reported by FDA | 2024-07-24 |
| Terminated | 2025-12-22 |
| Distributed | Nationwide (US) |
| Quantity | 5,752 bottles |
| Reason classes | specification failure |
| NDC | 57664-0231, 57664-0231-18, 57664-0231-88, 57664-0232, 57664-0232-18, 57664-0232-88, 57664-0233, 57664-0233-18, 57664-0233-88 |
| Lot numbers | 231067, 231069 |
| Expiration dates | 2025-04-30 |
Product
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.
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-0597-2024. 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.