The Recall Desk
LowFDA (Drugs)·D-0034-2018·Announced 2017-11-01

AbbVie Recalls AndroGel Testosterone Gel Due to Temperature Abuse

AbbVie is recalling 48 cartons of AndroGel testosterone gel distributed in Arizona due to prolonged exposure to temperatures outside labeled storage conditions.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is a storage condition deviation without reported injuries.

Plain-English summary

AbbVie Inc. is recalling 48 cartons of AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packets. The specific lot number is D60010A with an expiration date of 01/2019. The product is a prescription-only medication marketed by AbbVie Inc. in North Chicago, IL.

The recall was initiated because the product was subjected to temperature abuse, defined as prolonged exposure to temperatures outside of the labeled storage conditions. This deviation from storage requirements may affect the stability or quality of the medication.

The affected product was distributed in Arizona (AZ). Consumers and healthcare providers who have this specific lot of AndroGel should stop using it and contact their healthcare provider or the recalling firm for further instructions on disposal or replacement.

The recalled product

Product
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
Manufacturer
AbbVie Inc.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: D60010A
  • EXP. 01/2019

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by AbbVie Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →