CLASS II Drug recall · Reported 2 Aug 2023 · FDA Enforcement Report
Methylphenidate Hydrochloride Tablets, USP 20mg recalled
SUN Pharmaceutical Industries is recalling Methylphenidate Hydrochloride Tablets, USP 20mg, distributed nationwide in the US. The recall was initiated on 13 Jul 2023 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-0940-2023
- FDA event ID
- 92680
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jul 2023
- FDA classified
- 24 Jul 2023
- Reported
- 2 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- ADHD Medication
Timeline
| 13 Jul 2023 | Recall initiated by company | |
| 24 Jul 2023 | Classified by FDA | +11 days |
| 2 Aug 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Metal embedded in a tablet.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Metal embedded in a tablet.
Which lots are affected?
Lot AC74459, Exp 07/31/2024
Where was it sold?
Nationwide
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 SUN Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
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 | 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 |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 30 mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |