API Solutions Recalls Estriol USP41 Due to cGMP Deviations
API Solutions Inc. recalls Estriol USP41 Micro 25 Grams distributed by Syntec Pharma Corp due to current Good Manufacturing Practice deviations.
Use caution until it’s fixed
cGMP Deviations
Contact the company
What happened, in plain English
API Solutions Inc. is recalling Estriol USP41 Micro 25 Grams because the product was manufactured with current Good Manufacturing Practice (cGMP) deviations. The drug was distributed by Syntec Pharma Corp. to customers in Alabama, Arizona, Colorado, Florida, and Virginia. The recall affects a specific lot of 20 bottles. Read more at govinfonow.com/recall/36073-api-solutions-recalls-estriol-usp41-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/36073-api-solutions-recalls-estriol-usp41-due-to-cgmp-deviations · Updated October 10, 2026 · FDA enforcement record: FDA #D-0695-2021
Cite this page
“API Solutions Recalls Estriol USP41 Due to cGMP Deviations.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/36073-api-solutions-recalls-estriol-usp41-due-to-cgmp-deviations. Based on FDA recall #D-0695-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0695-2021%22&limit=1).
Why it’s dangerous
The hazard stems from cGMP deviations during the manufacturing process by Wuhan Fortune Chemical Co., Ltd. These deviations mean the product may not meet established quality standards, which could affect its safety or efficacy, though no specific adverse health events are listed in this record.
Who’s affected
Individuals or entities who purchased Estriol USP41 Micro 25 Grams from Syntec Pharma Corp. in Alabama, Arizona, Colorado, Florida, or Virginia are affected. The specific risk is tied to manufacturing quality control failures rather than a known immediate physical injury.
How to tell if you have this one
Check if you have Estriol USP41 Micro 25 Grams with NDC 46144-300-01 and Lot # ETL181001. The product has an expiration date of 10/09/2021. It was distributed by Syntec Pharma Corp. to states including AL, AZ, CO, FL, and VA.
- Brand
API Solutions- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
AL, AZ, CO, FL, VA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0695-2021 | 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; Lot #: ETL181001, Exp 10/09/2021 | 20 bottles |
| D-0696-2021 | 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; Lot #: AZA181105, Exp 11/09/2021 | 1 bottle |
What to do — step by step
Identify the Product
Verify if you have Estriol USP41 Micro 25 Grams with NDC 46144-300-01 and Lot # ETL181001.
Contact the Distributor
Reach out to Syntec Pharma Corp. for further instructions on how to handle this specific lot.
Where it went and when
Where it was distributed
Distributed in 5 states.
FDA distribution: “AL, AZ, CO, FL, VA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Colorado, Florida, Virginia.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0695-2021 (July 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0695-2021 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.