Amneal Recalls Subpotent Esterified Estrogens and Methyltestosterone Tablets
Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone Tablets because they failed potency testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which indicates the product is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Amneal Pharmaceuticals, Inc. is recalling 19,176 bottles of Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg. The affected product is distributed in 100-count bottles and is available by prescription only. The recall covers lots HL06015 and HL06115, which have an expiration date of 10/2017.
The recall was initiated because the tablets failed to meet the required potency standards, resulting in out-of-specification assay results. This means the medication may not contain the full amount of active ingredients intended, potentially reducing its effectiveness for patients.
The affected units were distributed nationwide within the United States. Patients and healthcare providers should stop using the recalled lots and contact their healthcare provider or pharmacist for a replacement or alternative treatment.
The recalled product
- Product
- 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
- Manufacturer
- Amneal Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 19,176
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: HL06015
- HL06115
- Exp. 10/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Amneal Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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