RecallRadar

FDA Drug recall D-0525-2018

Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4)

On 2018-02-28 the FDA classified a Class II recall of Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4) 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

AgencyFDA Drug
Recall numberD-0525-2018
ClassificationClass II
Statusterminated
Initiated2018-02-09
Published2018-02-28
Last updated2026-09-13 11:52 UTC
CompanyAmerican Pharmaceutical Ingredients
DistributionUS

Product

Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), 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) 071516-3, Exp. 04/01/2019; b) 071516-3, Exp. 4/1/2019; c) 071516-1, 071516-2, Exp. 04/01/2019; d) 071516-1, 0…Lot #: a) 071516-3, Exp. 04/01/2019; b) 071516-3, Exp. 4/1/2019; c) 071516-1, 071516-2, Exp. 04/01/2019; d) 071516-1, 071516-3, Exp. 04/01/2019, 032117B-1, Exp. 2/9/2020.

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-0525-2018%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.