Alfuzosin Hydrochloride Extended-release Tablets — Class II drug recall D-0502-2017
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2017-03-08, distributed nationwide. Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a br
| Recall number | D-0502-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2017-01-05 |
| Classified | 2017-03-01 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2018-06-29 |
| Distributed | Nationwide (US) |
| Quantity | 22,915 bottles |
| Reason classes | foreign material |
| NDC | 47335-0956, 47335-0956-08, 47335-0956-18, 47335-0956-81, 47335-0956-83, 47335-0956-88 |
| Lot numbers | 03/18, JKR5200A, JKR5219A, JKR5220A, JKR5221A, JKR5222A |
Product
Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, Gujarat, India, NDC 47335-956-88.
Reason for recall
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
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-0502-2017. 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.