Novartis Recalls Ritalin 10mg Due to Incorrect Medication Guide
Novartis recalls 10,930 bottles of Ritalin HCl 10mg tablets because the attached Medication Guide contains incorrect information for Ritalin SR.
Lower-risk 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
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What happened, in plain English
Novartis Pharmaceuticals Corp. is recalling Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per bottle due to a labeling error. The Medication Guide attached to the Package Insert incorrectly contains information related to Ritalin SR (Sustained Release) Tablets instead of the immediate-release tablets. This affects bottles distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/46226-novartis-pharmaceuticals-corp-recalls-ritalin-hcl-methylphenidate-hcl-usp-10.
Source Summary by GovInfoNow · govinfonow.com/recall/46226-novartis-pharmaceuticals-corp-recalls-ritalin-hcl-methylphenidate-hcl-usp-10 · Updated October 13, 2026 · FDA enforcement record: FDA #D-1227-2014
Cite this page
“Novartis Recalls Ritalin 10mg Due to Incorrect Medication Guide.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46226-novartis-pharmaceuticals-corp-recalls-ritalin-hcl-methylphenidate-hcl-usp-10. Based on FDA recall #D-1227-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1227-2014%22&limit=1).
Why it’s dangerous
The hazard is that the Medication Guide attached to the Package Insert was printed with information related to Ritalin SR (Sustained Release) Tablets. Because both products utilize a combined Package Insert, the individual guides are attached via perforation, but the wrong guide content could lead to confusion about how to take the medication.
Who’s affected
Patients who purchased or were prescribed the specific lot of Ritalin HCl 10 mg tablets from this recall are affected. While the medication itself is not defective, users may receive incorrect usage information for their specific prescription.
How to tell if you have this one
Check if you have Ritalin HCl (methylphenidate HCl) USP, 10 mg, in a bottle of 100 tablets. Look for NDC 0078-0440-05 and Lot # F0126. The product was manufactured by Novartis Pharmaceuticals Corp. in Suffern, NY, and distributed by Novartis in East Hanover, New Jersey.
- Brand
Novartis- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide and Puerto Rico- NDC
0078-0439-05, 0078-0440-05, 0078-0441-05
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1227-2014 | 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; Lot #: F0126 | 10,930 Bottles |
| D-1228-2014 | Ritalin HCl (methylphenidate HCl) USP, 20 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 0078-0441-05; Lot #: F0131 | 10,781 bottles |
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1227-2014 (March 3, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1227-2014 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.