Amneal Recalls Esterified Estrogens & Methyltestosterone Tablets
Amneal recalls 19,176 bottles of Esterified Estrogens & Methyltestosterone Tablets due to subpotent drug levels. Check your lot numbers and expiration date.
Use caution until it’s fixed
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Contact the company
What happened, in plain English
Amneal Pharmaceuticals is recalling 100-count bottles of Esterified Estrogens & Methyltestosterone Tablets (USP 1.25 mg/2.5 mg) because the assay results were out of specification, resulting in subpotent drug levels. The recall affects 19,176 units distributed nationwide within the United States. No remedy is currently stated in the record. Read more at govinfonow.com/recall/41171-amneal-recalls-esterified-estrogens-methyltestosterone-tablets.
Source Summary by GovInfoNow · govinfonow.com/recall/41171-amneal-recalls-esterified-estrogens-methyltestosterone-tablets · Updated October 11, 2026 · FDA enforcement record: FDA #D-1439-2019
Cite this page
“Amneal Recalls Esterified Estrogens & Methyltestosterone Tablets.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41171-amneal-recalls-esterified-estrogens-methyltestosterone-tablets. Based on FDA recall #D-1439-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1439-2019%22&limit=1).
Why it’s dangerous
The tablets contain subpotent levels of Esterified Estrogen and Methyltestosterone due to out-of-specification assay results. This means the medication may not deliver the expected dosage, potentially reducing its therapeutic effectiveness for patients who depend on it.
Who’s affected
Patients who have been prescribed or possess 100-count bottles of this specific medication manufactured by Amneal Pharmaceuticals and distributed by Seton Pharmaceuticals. Individuals relying on the full potency of these hormones for treatment are most at risk.
How to tell if you have this one
Check your bottle for NDC 13925-172-01 and Lot numbers HL06015 or HL06115 with an expiration date of 10/2017. The product is a prescription-only, 100-count bottle manufactured by Amneal Pharmaceuticals of NY in Hauppauge, NY.
- Brand
Amneal Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1438-2019 | Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01; Lot #: HL05715, HL05815, Exp. 11/2017 | 19104 units |
| D-1439-2019 | Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01; Lot #: HL06015, HL06115, Exp. 10/2017 | 19176 units |
What to do — step by step
Check your medication
Verify if you have bottles with NDC 13925-172-01 and Lot numbers HL06015 or HL06115 expiring in 10/2017.
Consult your doctor
Contact your healthcare provider to discuss whether you have the recalled product and what steps to take regarding your treatment.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #D-1439-2019 (September 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1439-2019 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.