# FDA recall D-0391-2019

> **Sun Pharmaceutical Industries, Inc.** · Class III · drug recall initiated 2018-12-26.

## Product

LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL,  24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256  Ohm Laboratories Inc. UPC 0 93351 11270 6 NDC#:53943-123-24

## Reason for recall

Labeling Not Elsewhere Classified:  The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.

## Distribution

OH

## Key facts

- **Recall number:** D-0391-2019
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-12-26
- **Report date:** 2019-01-30
- **Termination date:** 2020-04-02

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0391-2019

## Citation

> AI Analytics. FDA recall D-0391-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0391-2019. Source: US FDA. Licensed CC0.

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