CLASS III ONGOING Drug recall · Reported 24 Jun 2026 · FDA Enforcement Report
Focalin XR (dexmethylphenidate HCl) 5 mg recalled by Sandoz
Sandoz is recalling Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per, distributed nationwide in the US. The recall was initiated on 1 Jun 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0608-2026
- FDA event ID
- 99121
- Recalling firm
- Sandoz, Princeton, NJ
- Brand
- Focalin
- Manufacturer
- Sandoz Inc
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 1 Jun 2026
- FDA classified
- 22 Jun 2026
- Reported
- 24 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- ADHD Medication
Timeline
| 1 Jun 2026 | Recall initiated by company | |
| 22 Jun 2026 | Classified by FDA | +21 days |
| 24 Jun 2026 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Product as listed by the FDA
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date
Which lots are affected?
Lot VA0099422; Exp. Date June 30, 2028
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Dexmethylphenidate recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dexmethylphenidate HCl Extended-Release, Capsules, 10mg recalled | Novartis Pharmaceuticals | Potency & Assay | NJ |