Novartis Recalls Ritalin Tablets Due to Incorrect Medication Guide Labeling
Novartis is recalling Ritalin tablets because the attached Medication Guide contained information for the sustained-release version. The recall is limited to a specific lot distributed nationwide and in Puerto Rico.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically low severity (score 1 or 2) because it is unlikely to cause adverse health consequences. The issue is a labeling error involving the wrong medication guide, not a contamination or dosage error.
Plain-English summary
Novartis Pharmaceuticals Corp. is recalling 10,930 bottles of Ritalin (methylphenidate hydrochloride) 10 mg tablets. The recall was initiated because the Medication Guide attached to the package insert was printed with information related to Ritalin SR (Sustained Release) Tablets instead of the immediate-release tablets. Both products utilize a combined package insert, but the individual Medication Guides are attached via a perforation.
The affected product is Ritalin HCl USP, 10 mg, 100 tablets per bottle, with NDC 0078-0440-05. The specific lot number is F0126. The product was distributed nationwide and in Puerto Rico.
Consumers with this specific lot of Ritalin tablets should contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- RITALIN (METHYLPHENIDATE HYDROCHLORIDE)
- Brand
- RITALIN
- Manufacturer
- Novartis Pharmaceuticals Corp.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 10,930
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: F0126
UPCs (2)
- 0300780441056
- 0300780439053
Distribution
Part of a larger recall action
This product is one of 2 recalled by Novartis Pharmaceuticals Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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