Focalin XR — Class III drug recall D-0608-2026
Ongoing recall by Sandoz Inc, reported 2026-06-24, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date
| Recall number | D-0608-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2026-06-01 |
| Classified | 2026-06-22 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 7,803 bottles |
| Reason classes | labeling |
| NDC | 66758-0235, 66758-0235-01, 66758-0235-31, 66758-0236, 66758-0236-01, 66758-0236-31, 66758-0237, 66758-0237-01, 66758-0237-31, 66758-0238, 66758-0238-01, 66758-0238-31, 66758-0239, 66758-0239-01, 66758-0239-31, 66758-0240, 66758-0240-01, 66758-0240-31, 66758-0241, 66758-0241-01, 66758-0241-31, 66758-0242, 66758-0242-01, 66758-0242-31 |
| Lot numbers | VA0099422 |
| Expiration dates | 2028-06-30 |
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
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0608-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.