CLASS III Drug recall · Reported 16 Apr 2014 · FDA Enforcement Report

Ritalin HCl (methylphenidate HCl) USP, 10 mg recalled

Novartis Pharmaceuticals is recalling Ritalin HCl (methylphenidate HCl) USP, 10 mg per, distributed nationwide in the US. The recall was initiated on 3 Mar 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: F0126

Quantity recalled10,930 Bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1227-2014
FDA event ID: 67633
Recalling firm: Novartis Pharmaceuticals, Suffern, NY
Classification: Class III
Status: Terminated
Recall initiated: 3 Mar 2014
FDA classified: 8 Apr 2014
Reported: 16 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: ADHD Medication

Timeline

3 Mar 2014	Recall initiated by company
8 Apr 2014	Classified by FDA	+36 days
16 Apr 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901, Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0440-05

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #: F0126

Where was it sold?

Nationwide and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 67633

Reported	Class	Recall	Company	Reason	Where
16 Apr 2014	CLASS III	Ritalin HCl (methylphenidate HCl) USP, 20 mg recalled	Novartis Pharmaceuticals	Packaging Defects	Nationwide

More recalls from Novartis Pharmaceuticals

All 33

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Drug	CLASS II	Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan	Novartis Pharmaceuticals	Potency & Assay	Nationwide
13 Dec 2023Drug	CLASS I	Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalled	Novartis Pharmaceuticals	Other	Nationwide
27 Sep 2023Drug	CLASS I	Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalled	Novartis Pharmaceuticals	Other	Nationwide
5 Oct 2022Drug	CLASS II	Neoral soft gelatin capsules (cyclosporine capsules recalledNeoral	Novartis Pharmaceuticals	Potency & Assay	Nationwide
15 Jun 2022Drug	CLASS III	Xiidra (lifitegrast ophthalmic solution) recalledXiidra	Novartis Pharmaceuticals	Potency & Assay	Nationwide

Other Ritalin (methylphenidate recalls

All 2

Reported	Class	Recall	Company	Reason	Where
16 Apr 2014Drug	CLASS III	Ritalin HCl (methylphenidate HCl) USP, 20 mg recalled	Novartis Pharmaceuticals	Packaging Defects	Nationwide