Novartis Recalls Ritalin Tablets Due to Incorrect Medication Guide Labeling
Novartis is recalling 10,781 bottles of Ritalin 20 mg tablets because the attached Medication Guide contained information for Ritalin SR instead of Ritalin Tablets.
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 recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is a labeling error involving the wrong medication guide, which is a documentation/packaging problem rather than a direct safety hazard like contamination or dosage error.
Plain-English summary
Novartis Pharmaceuticals Corp. is recalling 10,781 bottles of Ritalin (methylphenidate hydrochloride) 20 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 rather than the immediate-release Ritalin Tablets. Both products utilize a combined package insert, but the specific Medication Guide attached to the Ritalin Tablets was incorrect.
The affected product is Ritalin HCl USP, 20 mg, 100 tablets per bottle, prescription only. The specific lot number is F0131. The product was distributed nationwide and in Puerto Rico. The NDC for the recalled product is 0078-0441-05.
Consumers and healthcare providers should check their inventory for Ritalin 20 mg tablets with Lot # F0131. If found, the product should be returned to the pharmacy or Novartis for replacement or refund. Patients should consult their healthcare provider if they have questions regarding the medication guide or their prescription.
The recalled product
- Product
- RITALIN (METHYLPHENIDATE HYDROCHLORIDE)
- Brand
- RITALIN
- Manufacturer
- Novartis Pharmaceuticals Corp.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 10,781
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 #: F0131
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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