The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0110-2018·Announced 2017-12-27

Osmotica Recalls Subpotent Methylphenidate Hydrochloride Extended-Release Tablets

Osmotica Pharmaceutical Corp is voluntarily recalling 10,064 bottles of subpotent Methylphenidate Hydrochloride Extended-Release Tablets nationwide.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor defects.

Plain-English summary

Osmotica Pharmaceutical Corp is voluntarily recalling 10,064 bottles of Methylphenidate Hydrochloride Extended-Release Tablets, USP 27 mg, 100-count bottles. The product is manufactured by Trigen Laboratories, LLC, located in Bridgewater, NJ, and carries the NDC 13811-707-10. The specific lot affected is 170027A, with an expiration date of 02/2019.

The recall was initiated because the product was found to be subpotent, meaning it did not contain the full amount of the active ingredient required by the United States Pharmacopeia (USP) standards. This is a Class III recall, which indicates that the violation is not likely to cause adverse health consequences. The recall is voluntary and was initiated by the firm.

The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement. No specific instructions for disposal are provided in the source text, but standard pharmacy return procedures apply.

The recalled product

Product
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Brand
METHYLPHENIDATE HYDROCHLORIDE
Manufacturer
Osmotica Pharmaceutical Corp
Category
Drug — Prescription Drug
Hazard
Affected units
10,064

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 #: 170027A
  • Exp. 02/2019

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 →

Related recalls

Same brand · METHYLPHENIDATE HYDROCHLORIDE

Same manufacturer · Osmotica Pharmaceutical Corp

See all →

Same hazard · subpotent drug

See all →

Similar recalls