FDA Drug recall D-0034-2018
AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton
- FDA Drug
- Class III
- terminated
- Published 2017-11-01
On 2017-11-01 the FDA classified a Class III recall of AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton by Abbvie, citing temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0034-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-09-08 |
| Published | 2017-11-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Abbvie |
| Distribution | AZ |
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
Reason
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Identifiers
| code_info | Lot: D60010A, EXP. 01/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0034-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.