FDA Drug recall D-0413-2018
NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc.…
- FDA Drug
- Class III
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class III recall of NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc.… by Allergan, citing labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0413-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-02-02 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Allergan |
| Distribution | US |
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
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Identifiers
| code_info | Lot # 544821A, Exp 07/19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0413-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.