# FDA recall D-0606-2018

> **Glenmark Pharmaceuticals Inc., USA** · Class III · drug recall initiated 2018-03-19.

## Product

Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ  07430, NDC 68462-302-01.

## Reason for recall

Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.

## Distribution

Nationwide in the United States.

## Key facts

- **Recall number:** D-0606-2018
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-03-19
- **Report date:** 2018-04-04
- **Termination date:** 2019-12-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0606-2018

## Citation

> AI Analytics. FDA recall D-0606-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0606-2018. Source: US FDA. Licensed CC0.

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