CLASS III Drug recall · Reported 1 Nov 2017 · FDA Enforcement Report
AndroGel (testosterone gel) 1.62%, 40.5mg in aluminum recalled by AbbVie
AbbVie is recalling AndroGel (testosterone gel) 1.62%, 40.5mg in aluminum, distributed in Arizona. The recall was initiated on 8 Sep 2017 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-0034-2018
- FDA event ID
- 78143
- Recalling firm
- AbbVie, North Chicago, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Sep 2017
- FDA classified
- 25 Oct 2017
- Reported
- 1 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Hormones & Birth Control
Timeline
| 8 Sep 2017 | Recall initiated by company | |
| 25 Oct 2017 | Classified by FDA | +47 days |
| 1 Nov 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30
Where it was distributed
AZ
Questions about this recall
Why was it recalled?
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Which lots are affected?
Lot: D60010A, EXP. 01/2019
Where was it sold?
AZ
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.
Other products in this recall event
1 other product · FDA event 78143| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump recalled | AbbVie | Temperature Abuse | AZ |
More recalls from AbbVie
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pred Mild, prednisolone acetate ophthalmic suspension recalled by AbbViePred Mild | AbbVie | Potency & Assay | Nationwide |
| Drug | CLASS II | Refresh Lacri-lube, (42.5% Mineral Oil recalled by AbbVie | AbbVie | Sterility | Nationwide |
| Drug | CLASS II | Refresh P.M., (Mineral Oil recalled by AbbVie | AbbVie | Sterility | Nationwide |
| Drug | CLASS III | Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg) recalledSynthroid | AbbVie | Other | IL |
| Drug | CLASS III | Ultane (sevoflurane), Inhalation Anesthetic recalled by AbbVieUltane | AbbVie | Packaging Defects | MS, OH |
Other Androgel (testosterone recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump recalled | AbbVie | Temperature Abuse | AZ |