Recall Record

Hawthorne, NY, United States

SUN PHARMA /TARO recalls

2 recalls recorded since 2018, most recently on 31 August 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0

Ongoing Class II Drugs

Recall started
31 August 2026
Reason
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0848-2026

Ongoing Class II Drugs

Recall started
9 December 2025
Reason
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Distribution
Nationwide within the United States
Initiated
Voluntary: Firm initiated
Recall number
D-0240-2026

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.