CLASS III Drug recall · Reported 21 Feb 2018 · FDA Enforcement Report
Norco (Hydrocodone Bitartrate and Acetaminophen) Tablets recalled
Allergan is recalling Norco (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, distributed nationwide in the US. The recall was initiated on 2 Feb 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0413-2018
- FDA event ID
- 79080
- Recalling firm
- Allergan, Madison, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Feb 2018
- FDA classified
- 9 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 2 Feb 2018 | Recall initiated by company | |
| 9 Feb 2018 | Classified by FDA | +7 days |
| 21 Feb 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Which lots are affected?
Lot # 544821A, Exp 07/19
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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