FDA DrugsClass III
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottl...
Published: June 24, 2026Recall ID: D-0608-2026Category: drugsCountry: US
Reason for Recall / Hazard
Labeling: Incorrect or Missing Lot and/or Exp Date
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Openfda › Unii | 1678OK0E08 |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 899439 |
| Openfda › Rxcui › 2 | 899441 |
| Openfda › Rxcui › 3 | 899461 |
| Openfda › Rxcui › 4 | 899463 |
| Openfda › Rxcui › 5 | 899485 |
| Openfda › Rxcui › 6 | 899487 |
| Openfda › Rxcui › 7 | 899495 |
| Openfda › Rxcui › 8 | 899497 |
| Openfda › Rxcui › 9 | 899511 |
| Openfda › Rxcui › 10 | 899513 |
| Openfda › Rxcui › 11 | 1006608 |
| Openfda › Rxcui › 12 | 1006610 |
| Openfda › Rxcui › 13 | 1101926 |
| Openfda › Rxcui › 14 | 1101928 |
| Openfda › Rxcui › 15 | 1101932 |
| Openfda › Rxcui › 16 | 1101934 |
| Openfda › Spl id | 525ad849-4502-493d-a0a1-67cde0a207f0 |
| Openfda › Brand name | FOCALIN |
| Openfda › Spl set id | 9cf76f62-48aa-4065-94fd-6fc910391ab5 |
| Openfda › Package ndc › 1 | 66758-240-01 |
| Openfda › Package ndc › 2 | 66758-240-31 |
| Openfda › Package ndc › 3 | 66758-239-01 |
| Openfda › Package ndc › 4 | 66758-239-31 |
| Openfda › Package ndc › 5 | 66758-241-01 |
| Openfda › Package ndc › 6 | 66758-241-31 |
| Openfda › Package ndc › 7 | 66758-242-01 |
| Openfda › Package ndc › 8 | 66758-242-31 |
| Openfda › Package ndc › 9 | 66758-237-01 |
| Openfda › Package ndc › 10 | 66758-237-31 |
| Openfda › Package ndc › 11 | 66758-235-01 |
| Openfda › Package ndc › 12 | 66758-235-31 |
| Openfda › Package ndc › 13 | 66758-236-01 |
| Openfda › Package ndc › 14 | 66758-236-31 |
| Openfda › Package ndc › 15 | 66758-238-01 |
| Openfda › Package ndc › 16 | 66758-238-31 |
| Openfda › Product ndc › 1 | 66758-235 |
| Openfda › Product ndc › 2 | 66758-240 |
| Openfda › Product ndc › 3 | 66758-239 |
| Openfda › Product ndc › 4 | 66758-241 |
| Openfda › Product ndc › 5 | 66758-242 |
| Openfda › Product ndc › 6 | 66758-237 |
| Openfda › Product ndc › 7 | 66758-236 |
| Openfda › Product ndc › 8 | 66758-238 |
| Openfda › Generic name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| Openfda › Manufacturer name | Sandoz Inc |
| Openfda › Application number | NDA021802 |
| Openfda › Is original packager | true |
| Event id | 99121 |
| Address 1 | 100 College Rd W |
| Code info | Lot VA0099422; Exp. Date June 30, 2028 |
| Postal code | 08540-6604 |
| Report date | 20260624 |
| Product type | Drugs |
| Product quantity | 7,803 bottles |
| Reason for recall | Labeling: Incorrect or Missing Lot and/or Exp Date |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260601 |
| Initial firm notification | Letter |
| Center classification date | 20260622 |
Overview
- Recalling FirmSandoz Inc
- StatusOngoing
- Risk LevelClass III
- DistributionU.S. Nationwide