Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78764

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 18, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Osmotica Pharmaceutical Corp

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10

D-0110-2018
Recall number
D-0110-2018
Initiated
December 18, 2017
Classification
Class III
Status
Terminated
Quantity
10064 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug

Code information

Lot #: 170027A, Exp. 02/2019

Distribution pattern

Nationwide

drug · product 2 of 2

Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10

D-0111-2018
Recall number
D-0111-2018
Initiated
December 18, 2017
Classification
Class III
Status
Terminated
Quantity
9919 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug

Code information

Lot #: 170029A, Exp. 02/2019; 170030A, Exp. 02/2019

Distribution pattern

Nationwide