# FDA recall D-0082-2018

> **Jubilant Cadista Pharmaceuticals, Inc.** · Class III · drug recall initiated 2017-10-30.

## Product

Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06

## Reason for recall

Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0082-2018
- **Recalling firm:** Jubilant Cadista Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-10-30
- **Report date:** 2017-11-22
- **Termination date:** 2020-02-12

- **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-0082-2018

## Citation

> AI Analytics. FDA recall D-0082-2018. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-0082-2018. Source: US FDA. Licensed CC0.

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