ANI Pharmaceuticals recalls Estradiol Gel 0.1% (0.25 mg per packet) due to defective containers that may be empty or partially full. This prescription-only product was distributed with NDC 70954-531-2: Lot M251109, exp Nov 2027.
Defective Container; packets were found to be either empty or partially full.
ANI Pharmaceuticals is recalling estradiol gel 0.1% (0.25 mg per packet) because some containers may be empty or partially full. This could lead to incorrect dosing if the gel is not properly measured. The product is prescription-only and distributed in 30-packet cartons.
The containers may be empty or partially full, which could result in incorrect dosing if the patient uses the gel without properly measuring the amount. This is a medication error risk but does not involve immediate physical harm.
Prescription patients who have received this specific estradiol gel product. Those with the NDC 70954-531-20 and lot number M251109 are most at risk.
Check for the NDC code 70954-531-20 and lot number M251109 on the product packaging. The product is a prescription-only estradiol gel sold in 30-packet cartons.
Look for the NDC code 70954-531-20 and lot number M251109 on the product packaging.
The product may have defective containers that are empty or partially full, which could lead to incorrect dosing. However, the recall does not indicate immediate safety risks.
Check for the NDC code 70954-531-20 and lot number M251109 on the product packaging. The product is a prescription-only estradiol gel sold in 30-packet cartons.
The recall does not specify a remedy, so no action is required beyond checking the product packaging for the NDC and lot numbers.
We’ve drafted a message you can send ANI Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0543-2026 — ANI Pharmaceuticals ANI Pharmaceuticals Hello, I own a ANI Pharmaceuticals that is covered by recall D-0543-2026 from ANI Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
