The Recall Desk
ModerateFDA (Drugs)·D-848-2013·Announced 2013-08-14

Teva Recalls Methylphenidate Hydrochloride Capsules Due to Dissolution Failures

Teva Pharmaceuticals is recalling 13,478 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct toxicological or structural defect, fitting the Moderate severity criteria for low-risk contamination or quality issues without reported injuries.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 13,478 bottles of Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count. The product is a prescription-only medication distributed nationwide. The recall was initiated because the product failed to meet dissolution specifications during routine stability testing.

The affected product is identified by NDC 0093-5347-01. Specific lot codes involved in the recall include 34010290A, 34010291A, 34010292A, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, and 34013218A. The expiration dates for these lots are 04/14 and 06/14.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider regarding alternative treatment options if they are currently using this medication.

The recalled product

Product
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Brand
METHYLPHENIDATE HYDROCHLORIDE
Manufacturer
Teva Pharmaceuticals USA, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
13,478

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • 34010290A
  • 34010291A
  • 34010292A
  • exp 04/14
  • 34011855A
  • 34011856A
  • 34011857A
  • 34011858A
  • 34013216A
  • 34013217A
  • 34013218A
  • exp 06/14.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Teva Pharmaceuticals USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same brand · METHYLPHENIDATE HYDROCHLORIDE

Same manufacturer · Teva Pharmaceuticals USA, Inc.

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Same hazard · quality control

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