FDA Drug recall D-0528-2018
Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4)
- FDA Drug
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4) by American Pharmaceutical Ingredients, citing CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0528-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-09 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Pharmaceutical Ingredients |
| Distribution | US |
Product
Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Reason
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Identifiers
| code_info | Lot #: a) b) 032117C-1, Exp. 02/11/2020; 070716-2, Exp. 03/22/2019; 121616-1, Exp. 08/20/2019; 071516-3, Exp. 4/1/2019…Lot #: a) b) 032117C-1, Exp. 02/11/2020; 070716-2, Exp. 03/22/2019; 121616-1, Exp. 08/20/2019; 071516-3, Exp. 4/1/2019; c) 032117C-1, Exp. 02/11/2020; 070716-1, Exp. 03/22/2019; 070716-2, Exp. 03/22/2019; 121616-1, Exp. 08/20/2019 d) 032117C-1, Exp. 02/11/2020; 061317-1, Exp. 4/30/2020; 061617-1, Exp. 05/01/2020; 070716-1, 070716-2, Exp. 03/22/2019; 121616-1, Exp. 8/20/2019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0528-2018%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.