Ritalin HCl — Class III drug recall D-1227-2014
Terminated recall by Novartis Pharmaceuticals Corp., reported 2014-04-16, distributed nationwide. Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert
| Recall number | D-1227-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Pharmaceuticals Corp., Suffern, NY, United States |
| Recall initiated | 2014-03-03 |
| Classified | 2014-04-08 |
| Reported by FDA | 2014-04-16 |
| Terminated | 2014-12-02 |
| Distributed | Nationwide (US) |
| Quantity | 10,930 bottles |
| Reason classes | labeling |
| NDC | 00078-0440-05 |
| Lot numbers | F0126 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1227-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.