Teva Recalls Methylphenidate Hydrochloride Extended-Release Capsules
Teva Pharmaceuticals is recalling 40 mg extended-release capsules due to failed dissolution specifications. Check your lot numbers and expiration dates.
Use caution until it’s fixed
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Contact the company
What happened, in plain English
Teva Pharmaceuticals USA, Inc. is recalling specific lots of Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, in 100-count bottles. The recall was initiated because the product failed dissolution specifications during routine stability testing. This means the medication may not release or absorb as intended. Read more at govinfonow.com/recall/47437-teva-pharmaceuticals-usa-inc-recalls-methylphenidate-hydrochloride-extended-release-capsules.
Source Summary by GovInfoNow · govinfonow.com/recall/47437-teva-pharmaceuticals-usa-inc-recalls-methylphenidate-hydrochloride-extended-release-capsules · Updated October 13, 2026 · FDA enforcement record: FDA #D-849-2013
Cite this page
“Teva Recalls Methylphenidate Hydrochloride Extended-Release Capsules.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/47437-teva-pharmaceuticals-usa-inc-recalls-methylphenidate-hydrochloride-extended-release-capsules. Based on FDA recall #D-849-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-849-2013%22&limit=1).
Why it’s dangerous
The capsules failed to meet dissolution specifications, which determine how a drug releases its active ingredient into the body over time. Because the dissolution was out of specification, the medication may not work as prescribed, potentially leading to inadequate treatment or unpredictable effects.
Who’s affected
Patients currently taking this specific prescription medication from Teva Pharmaceuticals are affected. Individuals who have filled prescriptions with the listed lot numbers and expiration dates are most at risk of receiving non-compliant product.
How to tell if you have this one
Look for Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, in 100-count bottles. Check the NDC number 0093-5348-01 and verify if your bottle has one of the following lot numbers: 34010287A, 34010288A, 34010289A (expiration 4/2014) or 34011513A, 34011514A, 34011515A (expiration 06/14).
- Brand
Teva Pharmaceuticals- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide- NDC
0093-5346-01, 0093-5347-01, 0093-5348-01
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-847-2013 | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01; 34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14. | 16,293 bottles |
| D-848-2013 | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01; 34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14. | 13,478 bottles |
| D-849-2013 | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01; 34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14. | 7,579 bottles |
What to do — step by step
Check Your Medication
Verify if your bottle matches the NDC 0093-5348-01 and has one of the recalled lot numbers or expiration dates.
Contact Your Pharmacist
Speak with your pharmacist to determine if you have a recalled bottle and discuss alternative treatment options.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Teva Pharmaceuticals recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-849-2013 (June 18, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-849-2013 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.