Sandoz Focalin XR 5 mg capsules recalled for label expiration error
Sandoz is recalling one lot of Focalin XR (dexmethylphenidate HCl) 5 mg extended-release capsules because some bottles have incorrect or missing lot numbers and expiration dates on the label. The affected lot (VA0099422) was distributed nationwide. This is a labeling issue only; the medication itself has not been found to be unsafe.
From the FDA notice · Read the official notice ↗
What to do
- Check your Focalin XR bottle label for lot number VA0099422.
- If your bottle is from this lot, contact your pharmacy or healthcare provider before using it.
- Do not discard the medication without guidance from your pharmacist or doctor.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 7,803 bottles
- Illnesses reported
- None reported
- Manufactured in
- 100 College Rd W, Princeton, NJ, United States
- Classification
- Class III
- Recall number
- D-0608-2026
In the FDA's words
- Description
- 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 Labeling: Incorrect or Missing Lot and/or Exp Date Lot VA0099422; Exp. Date June 30, 2028 Distribution: U.S. Nationwide Affected quantity: 7,803 bottles
- Hazard
- Labeling: Incorrect or Missing Lot and/or Exp Date