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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80187

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 24, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
LUPIN SOMERSET

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

1 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 1

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102

D-0836-2018
Recall number
D-0836-2018
Initiated
May 24, 2018
Classification
Class III
Status
Terminated
Recalling firm
LUPIN SOMERSET
Quantity
1,672 (1000-count) bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Missing Label

Code information

Lot # S800257; Exp. 01/20

Distribution pattern

OH

Field note

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