The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0573-2022·Announced 2022-03-02

Methylphenidate Hydrochloride Chewable Tablets Recalled for Failed Specifications

Rising Pharmaceuticals is voluntarily recalling Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, due to a tablet size defect. One tablet in a sealed bottle was found to be twice the size of other tablets in the same bottle.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this recall as Class II. The source explicitly states no illnesses or injuries have been reported. The defect involves a tablet size anomaly with no reported harm, making this a moderate-severity recall consistent with FDA Class II classification and voluntary precautionary action.

Plain-English summary

Rising Pharmaceuticals is voluntarily recalling Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottles, manufactured for Rising Pharmaceuticals Inc., Saddle Brook, NJ. The recall was initiated due to a market complaint reporting that a tablet in a sealed bottle was twice larger in size compared to the remaining tablets in that bottle.

The affected product is lot #25910009 with an expiration date of 01/2023. A total of 2220 100-count bottles were distributed nationwide in the USA.

This is the second complaint of this kind received regarding tablet size specifications. Consumers who have purchased this product should stop use and contact their pharmacy or healthcare provider with questions.

The recalled product

Product
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Brand
METHYLPHENIDATE HYDROCHLORIDE
Manufacturer
RISING PHARMACEUTICALS
Category
Drug — Prescription Tablet / Oral
Hazard

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 (2)

  • lot# 25910009
  • Exp 01/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · METHYLPHENIDATE HYDROCHLORIDE

Same manufacturer · RISING PHARMACEUTICALS

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