Amneal Pharmaceuticals recalls 100-count Esterified Estrogens & Methyltestosterone tablets (NDC 13925-172-01) due to subpotent drug levels. These prescription-only tablets may not contain enough active ingredients for effective treatment.
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Amneal Pharmaceuticals is recalling prescription Esterified Estrogens & Methyltestosterone tablets (100-count bottles) because lab tests showed they contain less active ingredient than labeled. This could lead to ineffective treatment if used as directed.
The tablets contain less active ingredient than specified in the lab tests. This means they may not provide the intended therapeutic effect when used as directed, potentially leading to ineffective hormone treatment.
Prescription patients who have received these specific 100-count tablets with NDC 13925-172-01 and lot numbers HL06015 or HL06115. Patients using these medications for hormone therapy are most at risk of ineffective treatment.
Check for 100-count bottles labeled 'Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg' with NDC 13925-172-01. Lot numbers HL06015 or HL06115 were produced in 2016 and expire October 2017.
Verify the product label, NDC number, and lot number to confirm if it's part of this recall.
The tablets contain less active ingredient than specified in lab tests, which could lead to ineffective treatment.
Check the label for NDC 13925-172-01 and lot numbers HL06015 or HL06115. If you have these, contact your doctor for alternative treatment options.
No immediate safety risks like injury or poisoning, but the tablets may not work as intended for hormone therapy.
We’ve drafted a message you can send Amneal Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1439-2019 — Amneal Pharmaceuticals Amneal Pharmaceuticals Hello, I own a Amneal Pharmaceuticals that is covered by recall D-1439-2019 from Amneal 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.
