Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0695-2021·Announced 2021-08-04

Drug Recall: Estriol USP41 Micro Due to cGMP Deviations

API Solutions Inc. is recalling Estriol USP41 Micro 25 Grams (Lot #ETL181001) due to cGMP deviations. The product was distributed to AL, AZ, CO, FL, and VA.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 due to cGMP deviations, which are manufacturing compliance issues. No illnesses, injuries, or specific hazards to patient safety are reported in the source text, making this a precautionary manufacturing-compliance recall rather than a direct safety threat.

Plain-English summary

API Solutions Inc. is voluntarily recalling Estriol USP41 Micro 25 Grams due to current Good Manufacturing Practice (cGMP) deviations. The recalled product is identified as Lot #ETL181001 with an expiration date of 10/09/2021, with NDC 46144-300-01. A total of 20 bottles were distributed to customers in Alabama, Arizona, Colorado, Florida, and Virginia. The product was manufactured by Wuhan Fortune Chemical Co., Ltd. in China and distributed by both A.P.I. Solutions in Daphne, AL and Syntec Pharma Corp. in New York.

Consumers or healthcare providers who have received this product should stop use and contact API Solutions Inc. for instructions on how to return or dispose of the product. This is an FDA Class II recall initiated by the manufacturer on July 15, 2021, and terminated on February 8, 2022.

The recalled product

Product: Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01
Manufacturer: API Solutions Inc.
Category: Drug — Pharmaceutical Active Ingredient
Hazard: cgmp-deviation
manufacturing-compliance
Affected units: 20

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 (2)

Lot #: ETL181001
Exp 10/09/2021

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 2 recalled by API Solutions Inc. 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 2 products in this recall →

Same manufacturer · API Solutions Inc.

See all →

Moderate
Azelaic Acid 99.0+% Micro 500G Drug Recalled for cGMP Deviations
FDA (Drugs) · 2021-08-04

Same hazard · cgmp deviation