ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.
Summary
The FDA issued a Class II for ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham by F.H. INVESTMENTS, Inc. (dba Asteria Health). Reason: Presence of Foreign substance - potential presence of metal particulate matter.
Details
Source
Drug Recall
External ID
D-0312-2026
Action Date
2026-02-18
Status
Ongoing
Category
drug
Product Description
ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.
Lot/Code Info: Lot#: 253000124, Exp. 06/02/2026.
Quantity Affected: 1,475 pellets
Reason for Recall
Presence of Foreign substance - potential presence of metal particulate matter
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-26
Company
Birmingham, AL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 73 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
F.H. INVESTMENTS, Inc. (dba Asteria Health) has 25 FDA actions in our database, including 25 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (F.H. INVESTMENTS, Inc. (dba Asteria Health)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does F.H. INVESTMENTS, Inc. (dba Asteria Health) have FDA actions?
F.H. INVESTMENTS, Inc. (dba Asteria Health) has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0312-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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