CLASS III Drug recall · Reported 28 Aug 2013 · FDA Enforcement Report
Mavik¿ trandolapril tablets 4mg recalled by AbbVie
AbbVie is recalling Mavik¿ trandolapril tablets 4mg, distributed nationwide in the US. The recall was initiated on 1 Aug 2013 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-901-2013
- FDA event ID
- 65851
- Recalling firm
- AbbVie, North Chicago, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Aug 2013
- FDA classified
- 20 Aug 2013
- Reported
- 28 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 1 Aug 2013 | Recall initiated by company | |
| 20 Aug 2013 | Classified by FDA | +19 days |
| 28 Aug 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect Package Insert; product packaged with outdated version of the insert
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Incorrect Package Insert; product packaged with outdated version of the insert
Which lots are affected?
Lot 22033GY
Where was it sold?
Nationwide
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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