RecallRadar

FDA Drug recall D-0650-2020

Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA

On 2020-01-15 the FDA classified a Class II recall of Estriol, USP, (Micronized), 0.06 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-0650-2020
ClassificationClass II
Statusterminated
Initiated2019-12-09
Published2020-01-15
Last updated2026-09-13 11:52 UTC
CompanyAsclemed Usa
DistributionCA

Product

Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36

Reason

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

Identifiers

code_infoLot Code/Exp. Date: 11061901, 04011903, 04221904, 04241904, 06031902, 07301905, 09061903, EXP 12/31/2020

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-0650-2020%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.