FDA Drug recall D-0735-2016
Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind
- FDA Drug
- Class II
- terminated
- Published 2016-03-09
On 2016-03-09 the FDA classified a Class II recall of Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind by Sun Pharma Global Fze, citing failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0735-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-11 |
| Published | 2016-03-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sun Pharma Global Fze |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Identifiers
| upc | 341616638684 |
|---|---|
| code_info | Lot #s: JKP2234A, JKP2235A, Exp 04/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0735-2016%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.