CLASS II ONGOING Drug recall · Reported 2 Mar 2022 · FDA Enforcement Report
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg recalled
Rising Pharmaceuticals is recalling Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, distributed nationwide in the US. The recall was initiated on 7 Feb 2022 and the FDA has classified it as Class II.
Check your package
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-0573-2022
- FDA event ID
- 89545
- Recalling firm
- Rising Pharmaceuticals, East Brunswick, NJ
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Feb 2022
- FDA classified
- 22 Feb 2022
- Reported
- 2 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- ADHD Medication
Timeline
| 7 Feb 2022 | Recall initiated by company | |
| 22 Feb 2022 | Classified by FDA | +15 days |
| 2 Mar 2022 | 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
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
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
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
Which lots are affected?
lot# 25910009, Exp 01/2023
Where was it sold?
Nationwide in the USA
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from Rising Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS II | Warfarin Sodium Tablets, USP 1 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Meclizine HCl Tablets, 25 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Packaging Defects | NJ |
| Drug | CLASS III | Timolol Maleate Sterile Opthalmic Solution recalledTimolol Maleate | Rising Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS III | Timolol Maleate USP, 0.5%, Sterile Opthalmic Solution recalledTimolol Maleate | Rising Pharmaceuticals | Sterility | Nationwide |
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Other Methylphenidate recalls
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg recalledMethylphenidate Hydrochloride | Trigen Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Methylphenidate Hydrochloride Tablets, USP 20mg recalledMethylphenidate Hydrochloride | SUN Pharmaceutical Industries | Foreign Material | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 20mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 15 mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 10mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |