The Recall Desk
ModerateFDA (Drugs)·D-0836-2020·Announced 2020-02-19

Teva Recalls Methylphenidate Hydrochloride Extended-Release Tablets Due to Missing Desiccant

Teva Pharmaceuticals is recalling specific bottles of Methylphenidate Hydrochloride Extended-Release tablets because they may be missing the desiccant packet.

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 typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect (missing desiccant) is a quality control issue that may affect drug stability but does not involve acute hazards like contamination or mislabeling of active ingredients.

Plain-English summary

Teva Pharmaceuticals USA is recalling Methylphenidate Hydrochloride Extended-Release tablets, 18 mg, 100-count bottles. The recall is limited to Lot #1332796 A with an expiration date of 11/2020. The product is a prescription-only medication (CII) distributed nationwide in the United States.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product bottles may be absent of the desiccant packet. The desiccant is included to maintain the stability and quality of the medication.

Consumers and healthcare providers with this specific lot of medication should stop using it and contact their pharmacist or Teva Pharmaceuticals for further instructions on how to return or dispose of the product.

The recalled product

Product
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Brand
METHYLPHENIDATE HYDROCHLORIDE

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 (2)

  • Lot #: 1332796 A
  • Exp 11/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Teva Pharmaceuticals USA 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 2 products in this recall →