AbbVie AndroGel Recall: FDA Class III

Why it was recalled

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

Product description

AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33

Lot numbers, UPCs & expiration codes

Lot: 91122, EXP. 01/2020

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0033-2018
Classification: Class III
Status: Terminated
Recall initiated: Sep 8, 2017
FDA report date: Nov 1, 2017
Quantity: 520 pumps
Recall type: Voluntary: Firm initiated
Recalling firm: AbbVie Inc.

Original FDA data

Every field from FDA enforcement report D-0033-2018, exactly as published.

Show all FDA fields

City: North Chicago
State: IL
Status: Terminated
Country: United States
Event ID: 78143
Address: 1 N Waukegan Rd
Code information: Lot: 91122, EXP. 01/2020
Postal code: 60064-1802
Report date: Nov 1, 2017
Product type: Drugs
Recall number: D-0033-2018
Classification: Class III
Recalling firm: AbbVie Inc.
Product quantity: 520 pumps
Termination date: Apr 23, 2018
Reason for recall: Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Voluntary / mandated: Voluntary: Firm initiated
Product description: AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33
Distribution pattern: AZ
Recall initiation date: Sep 8, 2017
Initial firm notification: Letter
Center classification date: Oct 25, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0033-2018, published Nov 1, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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AbbVie AndroGel Recall

Summary