# FDA recall D-0635-2020

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2019-12-13.

## Product

Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.

## Reason for recall

Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-0635-2020
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-13
- **Report date:** 2020-01-08
- **Termination date:** 2020-10-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0635-2020

## Citation

> AI Analytics. FDA recall D-0635-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0635-2020. Source: US FDA. Licensed CC0.

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