# FDA recall D-1227-2014

> **Novartis Pharmaceuticals Corp.** · Class III · drug recall initiated 2014-03-03.

## Product

Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901, Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0440-05

## Reason for recall

Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets.  Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert.  The individual Medication Guides are attached to the Package Insert via a perforation.  Although t

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1227-2014
- **Recalling firm:** Novartis Pharmaceuticals Corp.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-03-03
- **Report date:** 2014-04-16
- **Termination date:** 2014-12-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Suffern, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1227-2014

## Citation

> AI Analytics. FDA recall D-1227-2014. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1227-2014. Source: US FDA. Licensed CC0.

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