# FDA recall D-1288-2015

> **Ranbaxy Inc.** · Class II · drug recall initiated 2015-06-26.

## Product

Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only.  Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.

## Reason for recall

Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1288-2015
- **Recalling firm:** Ranbaxy Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-06-26
- **Report date:** 2015-08-12
- **Termination date:** 2016-04-29

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1288-2015

## Citation

> AI Analytics. FDA recall D-1288-2015. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1288-2015. Source: US FDA. Licensed CC0.

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