# FDA recall D-0735-2016

> **Sun Pharma Global Fze** · Class II · drug recall initiated 2016-02-11.

## 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.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0735-2016
- **Recalling firm:** Sun Pharma Global Fze
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-02-11
- **Report date:** 2016-03-09
- **Termination date:** 2017-05-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sharm, N/A, United Arab Emirates

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0735-2016

## Citation

> AI Analytics. FDA recall D-0735-2016. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-0735-2016. Source: US FDA. Licensed CC0.

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