Amneal Pharmaceuticals, Inc.: Esterified Estrogen and Methyltestosterone Tablets Recalled for Low Potency

What You Should Do

1. Check your medication bottles for Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg (NDC 13925-171-01) with lot numbers HL05715 or HL05815 and an expiration date of 11/2017.
2. Check your medication bottles for Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg (NDC 13925-172-01) with lot numbers HL06015 or HL06115 and an expiration date of 10/2017.
3. Immediately contact your healthcare provider or pharmacist to discuss your treatment and determine if a replacement prescription is necessary.
4. Return any remaining tablets from the affected lots to your pharmacy for a refund and to ensure the subpotent medication is properly handled.
5. Contact Amneal Pharmaceuticals, Inc. at their Brookhaven, New York facility or through your distributing pharmacy for further instructions regarding this recall.
6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Affected Products