The Recall Desk
ModerateFDA (Drugs)·D-0111-2018·Announced 2017-12-27

Osmotica Recalls Subpotent Methylphenidate Hydrochloride Extended-Release Tablets

Osmotica Pharmaceutical Corp is voluntarily recalling 9,919 bottles of subpotent Methylphenidate Hydrochloride Extended-Release Tablets distributed nationwide.

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 III, which indicates a remote possibility of adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than a direct physical hazard like contamination or injury.

Plain-English summary

Osmotica Pharmaceutical Corp is voluntarily recalling 9,919 bottles of Methylphenidate Hydrochloride Extended-Release Tablets, USP 54 mg, 100-count bottles. The product is manufactured by Trigen Laboratories, LLC, and is identified by NDC 13811-709-10. The recall was initiated on December 18, 2017, and is classified as Class III by the FDA.

The reason for the recall is that the drug is subpotent, meaning it may contain less than the labeled amount of the active ingredient. The affected lots are 170029A and 170030A, both with an expiration date of 02/2019. The product was distributed nationwide.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance. The recall was initiated by the firm and is currently terminated.

The recalled product

Product
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Brand
METHYLPHENIDATE HYDROCHLORIDE
Manufacturer
Osmotica Pharmaceutical Corp
Category
Drug — Prescription Drug
Hazard
Affected units
9,919

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 (3)

  • Lot #: 170029A
  • Exp. 02/2019
  • 170030A

UPCs (2)

  • 0313811706109
  • 0313811708103

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Osmotica Pharmaceutical Corp 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 →

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Same brand · METHYLPHENIDATE HYDROCHLORIDE

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Same hazard · subpotent drug

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