The Recall Desk
ModerateFDA (Drugs)·D-0837-2020·Announced 2020-02-19

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

Teva Pharmaceuticals USA is recalling 17,436 bottles of Methylphenidate Hydrochloride Extended-Release tablets because the product bottles may be missing desiccant.

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, but the specific deviation (missing desiccant) is a minor packaging issue that does not pose an immediate risk of serious injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Teva Pharmaceuticals USA is recalling 17,436 bottles of Methylphenidate Hydrochloride Extended-Release tablets USP (CII), 27 mg, 100-count. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where the product bottles may be absent of desiccant.

The affected product is identified by Lot # 1332799A with an expiration date of 11/2020. The NDC number is 62037-734-01. The product was distributed nationwide in the United States.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Brand
METHYLPHENIDATE HYDROCHLORIDE
Affected units
17,436

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 # 1332799A
  • 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 →