FDA Drug recall D-0597-2024
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt
- FDA Drug
- Class II
- terminated
- Published 2024-07-24
On 2024-07-24 the FDA classified a Class II recall of Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt by Sun Pharmaceutical Industries, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0597-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-07-09 |
| Published | 2024-07-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Failed Dissolution Specifications
Identifiers
| ndc | 57664-231-88 |
|---|---|
| ndc | 57664-231-18 |
| ndc | 57664-232-88 |
| ndc | 57664-232-18 |
| ndc | 57664-233-88 |
| ndc | 57664-233-18 |
| code_info | Lot #s: 231067, 231069, Exp 04/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0597-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.