AndroGel — Class III drug recall D-0033-2018
Terminated recall by AbbVie Inc., reported 2017-11-01, distributed in AZ. Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
| Recall number | D-0033-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AbbVie Inc., North Chicago, IL, United States |
| Recall initiated | 2017-09-08 |
| Classified | 2017-10-25 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2018-04-23 |
| Distributed | AZ |
| Quantity | 520 pumps |
| Reason classes | labeling, temperature control |
| NDC | 00051-8462-33 |
| Lot numbers | 91122 |
| Expiration dates | 2020-01 |
Product
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
Reason for recall
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0033-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.