CLASS III Drug recall · Reported 23 Oct 2019 · FDA Enforcement Report
Methylphenidate Hydrochloride Oral Solution 5mg recalled by KVK-Tech
KVK-Tech is recalling Methylphenidate Hydrochloride Oral Solution 5mg per, Sugar Free Alcohol Free, distributed nationwide in the US. The recall was initiated on 4 Oct 2019 and the FDA has classified it as Class III.
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-0142-2020
- FDA event ID
- 83851
- Recalling firm
- KVK-Tech, Newtown, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Oct 2019
- FDA classified
- 15 Oct 2019
- Reported
- 23 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- ADHD Medication
Timeline
| 4 Oct 2019 | Recall initiated by company | |
| 15 Oct 2019 | Classified by FDA | +11 days |
| 23 Oct 2019 | 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
Presence of Foreign Substance; Fiber particles.
Product as listed by the FDA
Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Is Methylphenidate Hydrochloride Oral Solution 5mg per, Sugar Free Alcohol Free recalled?
Yes. KVK-Tech recalled Methylphenidate Hydrochloride Oral Solution 5mg per, Sugar Free Alcohol Free on 4 Oct 2019. The recall is Class III and its status is Terminated. Recall number D-0142-2020.
Why was it recalled?
Presence of Foreign Substance; Fiber particles.
Which lots are affected?
Batch # 15315A, Exp. 02/2021
Where was it sold?
Nationwide in the U.S.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Methylphenidate recalls
All 55| 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 |