The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-847-2013·Announced 2013-08-14

Teva Recalls Methylphenidate Hydrochloride Capsules for Dissolution Failures

Teva Pharmaceuticals is recalling 16,293 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 involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct toxicological threat, and no injuries are reported.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 16,293 bottles of Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 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 0093-5346-01. The recall includes specific lot codes: 34010282A, 34010283A, 34010284A, 34010285A, 34010286A, and 34010565A with an expiration date of 04/14; and 34013199A, 34013200A, 34013201A, 34013202A, and 34013203A with an expiration date of 10/14.

Consumers and healthcare providers should check their inventory for these specific lot numbers 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. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Brand
METHYLPHENIDATE HYDROCHLORIDE
Manufacturer
Teva Pharmaceuticals USA, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
16,293

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 (11)

  • 34010282A
  • 34010283A
  • 34010284A
  • 34010285A
  • 34010286A and 34010565A
  • exp 04/14
  • 34013199A
  • 34013200A
  • 34013201A
  • 34013202A and 34013203A
  • exp 10/14.

UPCs (1)

  • 009353460134

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 →

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