CLASS II Drug recall · Reported 19 Feb 2020 · FDA Enforcement Report
Methylphenidate hydrochloride Extended-Release ablets recalled
Teva Pharmaceuticals USA is recalling Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, distributed nationwide in the US. The recall was initiated on 27 Jan 2020 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-0836-2020
- FDA event ID
- 84797
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jan 2020
- FDA classified
- 10 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- ADHD Medication
Timeline
| 27 Jan 2020 | Recall initiated by company | |
| 10 Feb 2020 | Classified by FDA | +14 days |
| 19 Feb 2020 | 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
CGMP deviations: Product bottle may be absent of desiccant.
Product as listed by the FDA
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
CGMP deviations: Product bottle may be absent of desiccant.
Which lots are affected?
Lot #: 1332796 A, Exp 11/2020
Where was it sold?
USA 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.
Other products in this recall event
1 other product · FDA event 84797This product is part of a recall event; the main page for the event is Methylphenidate hydrochloride Extended-Release ablets recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Methylphenidate hydrochloride Extended-Release ablets recalledMethylphenidate Hydrochloride | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | 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 |