FDAFDA · Food and drugs·Recall number D-0873-2026
Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.
Published October 7, 2026 · Recall initiated: September 8, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container; packets were found to be either empty or partially full.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ESTRADIOL
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Distributor
- Nationwide in the USA.
- Lot
- Lot # 245226005B, Exp Date: 04/30/2028.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Related recalls
- FDARanolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., …October 7, 2026
- FDAFOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management…October 7, 2026
- FDAZoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: …October 7, 2026
- FDAMedline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF,…September 30, 2026
- FDAEstradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmace…May 27, 2026
- FDAEstradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Lim…June 12, 2024
- FDAEstradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Li…June 12, 2024
- FDAESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. ND…January 3, 2024
Questions about this recall
Was Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3. recalled?
Yes. FDA published recall D-0873-2026 on October 7, 2026. Reported hazard: Defective Container; packets were found to be either empty or partially full.
What should I do if I have this product?
Voluntary: Firm initiated · Letter
How do I know if my unit is part of the recall?
Compare your product details with the notice. Brand: ESTRADIOL.
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.
Recalert also tracks expiration dates so you can sell stock before it becomes a loss.