# FDA recall D-0391-2026

> **Annora Pharma Private Limited** · Class III · drug recall initiated 2026-02-03.

## Product

Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.

## Reason for recall

Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg

## Distribution

TN

## Key facts

- **Recall number:** D-0391-2026
- **Recalling firm:** Annora Pharma Private Limited
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-02-03
- **Report date:** 2026-03-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hyderabad, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0391-2026

## Citation

> AI Analytics. FDA recall D-0391-2026. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/D-0391-2026. Source: US FDA. Licensed CC0.

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