Data Foundry

Drug recalls 2018

NORCO — Class III drug recall D-0413-2018

Terminated recall by ALLERGAN, reported 2018-02-21, distributed nationwide. Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication

Recall numberD-0413-2018
Product typeDrug
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmALLERGAN, Madison, NJ, United States
Recall initiated2018-02-02
Classified2018-02-09
Reported by FDA2018-02-21
Terminated2019-02-07
DistributedNationwide (US)
Quantity8 bottles
Reason classeslabeling
NDC00023-6022-01
Lot numbers07/19, 544821A

Product

NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.

Reason for recall

Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0413-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.