RecallRadar

FDA Drug recall D-0652-2020

Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA

On 2020-01-15 the FDA classified a Class II recall of Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA by Asclemed Usa, citing failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0652-2020
ClassificationClass II
Statusterminated
Initiated2019-12-09
Published2020-01-15
Last updated2026-09-13 11:52 UTC
CompanyAsclemed Usa
DistributionCA

Product

Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38

Reason

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Identifiers

code_info
Lot Code/Exp. Date: 11191804, 12281802, 01211902, 01281901, 02071903, 02221902, 03111903, 03251902, 04011905, 040919…Lot Code/Exp. Date: 11191804, 12281802, 01211902, 01281901, 02071903, 02221902, 03111903, 03251902, 04011905, 04091903, 04221907, 05211902, 06071902, 06241903, 07111903, 07301902, 08271902, 09061904, 09161902, EXP 12/31/2020; 09161901, 10091905, 10221902, 10311901, EXP 5/31/2021; 11211902, 10311902, EXP 8/31/2021

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-0652-2020%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.