AbbVie recalls AndroGel testosterone gel due to temperature abuse risk
AbbVie recalls 30-packs of AndroGel testosterone gel (1.62%, 40.5mg) for prolonged exposure to improper temperatures. This may affect safety if stored outside labeled conditions.
Lower-risk recall
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Contact the company
What happened, in plain English
AbbVie is recalling AndroGel testosterone gel (1.62%, 40.5mg) because it can be damaged by temperatures outside the labeled storage range. This could lead to safety issues if the product is exposed to incorrect temperatures. Read more at govinfonow.com/recall/41258-abbvie-recalls-androgel-testosterone-gel-due-to-temperature-abuse-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41258-abbvie-recalls-androgel-testosterone-gel-due-to-temperature-abuse-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0034-2018
Cite this page
“AbbVie recalls AndroGel testosterone gel due to temperature abuse risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41258-abbvie-recalls-androgel-testosterone-gel-due-to-temperature-abuse-risk. Based on FDA recall #D-0034-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0034-2018%22&limit=1).
Why it’s dangerous
Prolonged exposure to temperatures outside the labeled storage conditions can damage the product. This may cause the gel to become unsafe or ineffective if not stored correctly.
Who’s affected
People with prescriptions for AndroGel testosterone gel who store it outside the labeled temperature range. Those using the product without proper temperature control are at higher risk.
How to tell if you have this one
Check for AndroGel testosterone gel (1.62%, 40.5mg) in 2.5g aluminum foil packets, 30 per carton. The product is prescription-only and has NDC code 0051-8462-30.
- Brand
AbbVie- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
AZ
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0033-2018 | 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: 91122, EXP. 01/2020 | 520 pumps |
| D-0034-2018 | 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; Lot: D60010A, EXP. 01/2019 | 48 cartons (30 foil packets per carton) |
What to do — step by step
Check Storage Conditions
Ensure the gel is stored within the labeled temperature range to prevent damage.
Where it went and when
Where it was distributed
Distributed in Arizona.
FDA distribution: “AZ” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other AbbVie recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0034-2018 (September 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0034-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.