The Recall Desk
ModerateFDA (Drugs)·D-0652-2020·Announced 2020-01-15

Enovachem Recalls Estriol USP Micronized 0.24 g Due to Impurity Failures

Enovachem Pharmaceuticals is recalling Estriol USP (Micronized) 0.24 g because additional testing revealed out-of-specification impurity results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a quality control failure (impurities) without reported adverse health consequences, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Asclemed USA Inc. dba Enovachem Pharmaceuticals is recalling Estriol, USP, (Micronized), 0.24 g. The recall was initiated after additional testing identified out-of-specification impurity test results for the product.

The affected product is distributed by Enovachem Pharmaceuticals in Torrance, California, and carries NDC #76420-049-38. The source text does not specify the total quantity of product recalled, but the structured data indicates a product quantity of 56.4 gm. The product was distributed to six physician's offices within the state of California.

Patients who have received this medication should contact their healthcare provider for guidance on next steps. The source text does not provide specific instructions for consumers beyond the standard recall notification.

The recalled product

Product
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
Manufacturer
Asclemed USA Inc. dba Enovachem Pharmaceuticals
Category
Drug — Pharmaceutical
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Asclemed USA Inc. dba Enovachem Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Asclemed USA Inc. dba Enovachem Pharmaceuticals

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Same hazard · impurity

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