FDA Drug recall D-0608-2026
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC,…
- FDA Drug
- Class III
- ongoing
- Published 2026-06-24
On 2026-06-24 the FDA classified a Class III recall of Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC,… by Sandoz, citing labeling: Incorrect or Missing Lot and/or Exp Date.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0608-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-06-01 |
| Published | 2026-06-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sandoz |
| Distribution | US |
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
Labeling: Incorrect or Missing Lot and/or Exp Date
Identifiers
| ndc | 66758-240-01 |
|---|---|
| ndc | 66758-240-31 |
| ndc | 66758-239-01 |
| ndc | 66758-239-31 |
| ndc | 66758-241-01 |
| ndc | 66758-241-31 |
| ndc | 66758-242-01 |
| ndc | 66758-242-31 |
| ndc | 66758-237-01 |
| ndc | 66758-237-31 |
| ndc | 66758-235-01 |
| ndc | 66758-235-31 |
| ndc | 66758-236-01 |
| ndc | 66758-236-31 |
| ndc | 66758-238-01 |
| ndc | 66758-238-31 |
| code_info | Lot VA0099422; Exp. Date June 30, 2028 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0608-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.