The Recall Desk
HighFDA (Drugs)·D-0608-2026·Announced 2026-06-24

[pending] FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE)

Pending LLM rewrite. Source: FDA_DRUG D-0608-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Labeling: Incorrect or Missing Lot and/or Exp Date

The recalled product

Product
FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Brand
FOCALIN
Manufacturer
Sandoz Inc

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 (3)

  • Lot VA0099422
  • Exp. Date June 30
  • 2028

Distribution

Distributed nationwide across the United States.