# FDA recall D-0078-2022

> **MACLEODS PHARMA USA, INC** · Class III · drug recall initiated 2021-10-18.

## Product

Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA

## Reason for recall

Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0078-2022
- **Recalling firm:** MACLEODS PHARMA USA, INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-10-18
- **Report date:** 2021-11-03
- **Termination date:** 2024-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0078-2022

## Citation

> AI Analytics. FDA recall D-0078-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0078-2022. Source: US FDA. Licensed CC0.

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