Startseite/Alle Rückrufe/FDA-D-0608-2026
FDA DrugsClass III

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

Veröffentlicht: 24. Juni 2026Rückruf-ID: D-0608-2026Kategorie: Arzneimittel & MedikamenteLand: Vereinigte Staaten
US
PharmaceuticalFDA DrugsUSUS

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

Recalling Firm: Sandoz Inc

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Mitteilung übersetzenTranslate notice text, hazard warnings, and descriptions into any supported language.

Grund für den Rückruf / Gefahr

Labeling: Incorrect or Missing Lot and/or Exp Date

Produktbeschreibung & Identifikation

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

Betroffene Produkte

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

FieldValue
CityPrinceton
StateNJ
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Openfda › Spl id525ad849-4502-493d-a0a1-67cde0a207f0
Openfda › Brand nameFOCALIN
Openfda › Spl set id9cf76f62-48aa-4065-94fd-6fc910391ab5
Openfda › Package ndc › 166758-240-01
Openfda › Package ndc › 266758-240-31
Openfda › Package ndc › 366758-239-01
Openfda › Package ndc › 466758-239-31
Openfda › Package ndc › 566758-241-01
Openfda › Package ndc › 666758-241-31
Openfda › Package ndc › 766758-242-01
Openfda › Package ndc › 866758-242-31
Openfda › Package ndc › 966758-237-01
Openfda › Package ndc › 1066758-237-31
Openfda › Package ndc › 1166758-235-01
Openfda › Package ndc › 1266758-235-31
Openfda › Package ndc › 1366758-236-01
Openfda › Package ndc › 1466758-236-31
Openfda › Package ndc › 1566758-238-01
Openfda › Package ndc › 1666758-238-31
Openfda › Product ndc › 166758-235
Openfda › Product ndc › 266758-240
Openfda › Product ndc › 366758-239
Openfda › Product ndc › 466758-241
Openfda › Product ndc › 566758-242
Openfda › Product ndc › 666758-237
Openfda › Product ndc › 766758-236
Openfda › Product ndc › 866758-238
Openfda › Generic nameDEXMETHYLPHENIDATE HYDROCHLORIDE
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Substance nameDEXMETHYLPHENIDATE HYDROCHLORIDE
Openfda › Manufacturer nameSandoz Inc
Openfda › Application numberNDA021802
Openfda › Is original packagertrue
Event id99121
Address 1100 College Rd W
Code infoLot VA0099422; Exp. Date June 30, 2028
Postal code08540-6604
Report date20260624
Product typeDrugs
Product quantity7,803 bottles
Reason for recallLabeling: Incorrect or Missing Lot and/or Exp Date
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260601
Initial firm notificationLetter
Center classification date20260622

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal...?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Übersicht

  • Rückrufendes UnternehmenSandoz Inc
  • StatusOngoing
  • RisikostufeClass III
  • DistributionU.S. Nationwide
Recall Hazard Severity
High Alert (Class I)
Offizielle Behördenwarnung

📢 Warnung teilen

Alert family and friends to keep them safe. Copy this quick alert message:

🚨 SAFETY ALERT: Sandoz Inc - 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

Check if your household is affected:
https://therecallfile.com/de/recalls/focalin-xr-dexmethylphenidate-hcl-5-mg-30-extended-release-capsules-pe/FDA-D-0608-2026
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