SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Onl
Summary
The FDA issued a Class II for SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, by Apollo Care, LLC. Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material.
Details
Source
Drug Recall
External ID
D-0757-2026
Action Date
2026-08-19
Status
Ongoing
Category
drug
Product Description
SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04.
Lot/Code Info: Lot: AC-017275, Exp. 12/13/2026; AC-017282, AC-017285, Exp. 12/27/2026.
Quantity Affected: 4,250 vials.
Reason for Recall
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Distribution
Nationwide within the U.S
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-29
Company
Columbia, MO
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 28 drug recalls issued in the same week, part of 68 drug-related FDA actions this month.
Apollo Care, LLC has 28 FDA actions in our database, including 28 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 (Apollo Care, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apollo Care, LLC have FDA actions?
Apollo Care, LLC has 28 FDA actions in our database, including 28 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0757-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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