# FDA recall D-0767-2022

> **Jubilant Cadista Pharmaceuticals, Inc.** · Class I · drug recall initiated 2022-03-08.

## Product

Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06

## Reason for recall

Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride

## Distribution

Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.

## Key facts

- **Recall number:** D-0767-2022
- **Recalling firm:** Jubilant Cadista Pharmaceuticals, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-03-08
- **Report date:** 2022-04-06
- **Termination date:** 2022-11-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salisbury, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0767-2022

## Citation

> AI Analytics. FDA recall D-0767-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0767-2022. Source: US FDA. Licensed CC0.

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