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.
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 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.
- Hazard
- cgmp-deviation
- manufacturing-compliance
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:
- AL
- AZ
- CO
- FL
- VA
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27