Epithalon for Injection recall: Sterility Concern
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
Why was Epithalon for Injection recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: GG053025-002 within expiry
- Product
- Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
- Recalling firm
- GenoGenix LLC
- Distribution
- US Nationwide.
- Recall date
- October 15, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)