The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-849-2013·Announced 2013-08-14

Teva Recalls Methylphenidate Hydrochloride Extended-Release Capsules Due to Dissolution Failure

Teva Pharmaceuticals is recalling 7,579 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 typically indicates a situation where use of the product could cause temporary or medically reversible adverse health consequences. The hazard is a quality control issue (dissolution failure) rather than a direct safety hazard like contamination or mislabeling of a critical allergen, and no illnesses or injuries are reported in the source text.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 7,579 bottles of Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count. The product is a prescription-only medication distributed nationwide. The recall is due to out-of-specification dissolution results obtained during routine stability testing.

The affected product is identified by NDC 0093-5348-01. Specific lot codes include 34010287A, 34010288A, and 34010289A with an expiration date of 4/2014, as well as 34011513A, 34011514A, and 34011515A with an expiration date of 06/14.

Consumers and healthcare providers should check their inventory for these specific lot codes and expiration dates. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Brand
METHYLPHENIDATE HYDROCHLORIDE
Manufacturer
Teva Pharmaceuticals USA, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
7,579

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 (8)

  • 34010287A
  • 34010288A
  • 34010289A
  • exp 4/2014
  • 34011513A
  • 34011514A
  • and 34011515A
  • 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 · dissolution failure

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