Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0696-2021·Announced 2021-08-04

Azelaic Acid 99.0+% Micro 500G Drug Recalled for cGMP Deviations

API Solutions Inc. is voluntarily recalling Azelaic Acid 99.0+% Micro 500 Grams (Lot #AZA181105, Exp 11/09/2021) distributed in five states due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.

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: This is an FDA Class II recall involving cGMP deviations. The source text does not report any illnesses, injuries, or adverse events. The hazard is a manufacturing process deficiency rather than a confirmed contamination or defect, making this a moderate-severity, precautionary recall.

Plain-English summary

API Solutions Inc. is voluntarily recalling one batch of Azelaic Acid 99.0+% Micro 500 Grams. The product was manufactured by Yicheng Chemicals Corp. in China and distributed by Syntec Pharma Corp. in New York through API Solutions Inc. in Daphne, Alabama.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations. cGMP violations can affect the quality, purity, and potency of pharmaceutical products.

The affected lot is Lot #AZA181105 with an expiration date of 11/09/2021. Distribution was limited to Alabama, Arizona, Colorado, Florida, and Virginia.

Consumers and healthcare providers who have this product should stop using it and contact API Solutions Inc. for instructions on return or disposal. The FDA classified this as a Class II recall. The recall was voluntarily initiated by the firm on July 15, 2021, and was terminated on February 8, 2022.

The recalled product

Product: Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York
Manufacturer: API Solutions Inc.
Category: Drug — Topical / Pharmaceutical Active
Hazard: manufacturing-defect
cgmp-violation
Affected units: 1

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 #: AZA181105
Exp 11/09/2021

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
Drug Recall: Estriol USP41 Micro Due to cGMP Deviations
FDA (Drugs) · 2021-08-04

Same hazard · manufacturing defect