CLASS III Drug recall · Reported 1 Nov 2017 · FDA Enforcement Report
Methylphenidate Hydrochloride Tablets USP, 20 mg recalled
Teva Pharmaceuticals U is recalling Methylphenidate Hydrochloride Tablets USP, 20 mg, distributed nationwide in the US. The recall was initiated on 17 Oct 2017 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-0052-2018
- FDA event ID
- 78308
- Recalling firm
- Teva Pharmaceuticals U, North Wales, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Oct 2017
- FDA classified
- 26 Oct 2017
- Reported
- 1 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 17 Oct 2017 | Recall initiated by company | |
| 26 Oct 2017 | Classified by FDA | +9 days |
| 1 Nov 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Low out of specification results for dissolution.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Is Methylphenidate Hydrochloride Tablets USP, 20 mg recalled?
Yes. Teva Pharmaceuticals U recalled Methylphenidate Hydrochloride Tablets USP, 20 mg on 17 Oct 2017. The recall is Class III and its status is Terminated. Recall number D-0052-2018.
Why was it recalled?
Failed Dissolution Specifications: Low out of specification results for dissolution.
Which lots are affected?
Lot Number # 1156086M, Exp 08/18
Where was it sold?
Nationwide in the USA 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 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.
More recalls from Teva Pharmaceuticals U
All 196| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxylamine Succinate and Pyridoxine Hydrochloride recalledDoxylamine Succinate And Pyridoxine Hydrochloride | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) recalledMimvey | Teva Pharmaceuticals U | Labeling Errors | Nationwide |
| Drug | CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg recalledMimvey | Teva Pharmaceuticals U | Labeling Errors | Nationwide |
| Drug | CLASS II | Brinzolamide Ophthalmic Suspension recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Packaging Defects | Nationwide |
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 |