Allergan Recalls NORCO Tablets Due to Labeling Error
Allergan recalls specific lots of NORCO 10 mg/325 mg tablets because the primary label is missing the required CII controlled drug classification.
Use caution until it’s fixed
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Contact the company
What happened, in plain English
Allergan USA, Inc. is recalling NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg in 100-count bottles. The recall was issued because the primary label on these bottles does not display the required "CII" controlled drug classification indication. This is a Class III recall involving only eight bottles distributed nationwide. Read more at govinfonow.com/recall/40894-allergan-recalls-norco-tablets-due-to-labeling-error.
Source Summary by GovInfoNow · govinfonow.com/recall/40894-allergan-recalls-norco-tablets-due-to-labeling-error · Updated October 11, 2026 · FDA enforcement record: FDA #D-0413-2018
Cite this page
“Allergan Recalls NORCO Tablets Due to Labeling Error.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40894-allergan-recalls-norco-tablets-due-to-labeling-error. Based on FDA recall #D-0413-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0413-2018%22&limit=1).
Why it’s dangerous
The hazard is a labeling error where the mandatory "CII" designation for controlled substances is missing from the primary label. While the record does not describe a physical defect in the drug itself, the absence of required regulatory labeling can impact proper identification and handling of the controlled substance.
Who’s affected
Patients who have been prescribed or possess NORCO tablets from the specific lot identified in this recall are affected. Because the product is prescription-only (Rx Only), the risk is limited to individuals with a valid prescription for this specific medication.
How to tell if you have this one
Check your medication bottles for the following details: Brand NORCO, Strength 10 mg/325 mg, NDC 0023-6022-01, Lot # 544821A, and Expiration Date 07/19. The product is distributed by Allergan USA, Inc., located in Irvine, CA.
- Brand
Allergan- Category
Drug
What to do — step by step
Check Your Medication
Verify if your NORCO bottle matches Lot # 544821A and NDC 0023-6022-01.
Contact Your Pharmacist
If you have the affected lot, contact your pharmacy or healthcare provider for instructions on how to proceed with the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0413-2018 (February 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0413-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.