CLASS II Drug recall · Reported 4 Aug 2021 · FDA Enforcement Report

Azelaic Acid 0+% Micro recalled by API Solutions

API Solutions is recalling Azelaic Acid 0+% Micro, distributed in Alabama, Arizona, Colorado, Florida, Virginia. The recall was initiated on 15 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: AZA181105, Exp 11/09/2021

Quantity recalled1 bottle

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0696-2021
FDA event ID: 88289
Recalling firm: API Solutions, Daphne, AL
Classification: Class II
Status: Terminated
Recall initiated: 15 Jul 2021
FDA classified: 28 Jul 2021
Reported: 4 Aug 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations

Timeline

15 Jul 2021	Recall initiated by company
28 Jul 2021	Classified by FDA	+13 days
4 Aug 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

cGMP Deviations

Product as listed by the FDA

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

Where it was distributed

AL, AZ, CO, FL, VA

Alabama Arizona Colorado Florida Virginia

Questions about this recall

Is Azelaic Acid 0+% Micro recalled?

Yes. API Solutions recalled Azelaic Acid 0+% Micro on 15 Jul 2021. The recall is Class II and its status is Terminated. Recall number D-0696-2021.

Why was it recalled?

cGMP Deviations

Which lots are affected?

Lot #: AZA181105, Exp 11/09/2021

Where was it sold?

AL, AZ, CO, FL, VA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.