Alendronate Sodium Tablets — Class II drug recall D-0735-2016
Terminated recall by Sun Pharma Global Fze, reported 2016-03-09, distributed nationwide. Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specificat
| Recall number | D-0735-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharma Global Fze, Sharm, N/A, United Arab Emirates |
| Recall initiated | 2016-02-11 |
| Classified | 2016-03-03 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2017-05-23 |
| Distributed | Nationwide (US) |
| Quantity | 381,120 cartons |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00341616638684 |
| NDC | 41616-0638-68 |
| Lot numbers | 04/17, JKP2234A, JKP2235A |
Product
Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4.
Reason for recall
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
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-0735-2016. 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.