Apollo Care Recalls Semaglutide Vials Due to Particulate Matter
Apollo Care, LLC is recalling specific lots of Semaglutide 2.25mg vials because they contain nylon and silk-type particulate matter.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the presence of particulate matter in a sterile injectable drug poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Apollo Care, LLC is voluntarily recalling 23,029 vials of Semaglutide 2.25mg (0.9 mg/mL), 2.5 mL sterile multi-dose vials. The recall was initiated due to the presence of particulate matter, which was identified as nylon/polyamide and silk/proteinaceous-type material.
The affected product is distributed nationwide within the U.S. The specific lots subject to the recall are AC-017114 (Exp. 11/24/2026), AC-017164, AC-017204, and AC-017205 (Exp. 12/31/2026). The product is prescription-only and intended for subcutaneous injection.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be discontinued and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02
- Manufacturer
- Apollo Care, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 23,029
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 (6)
- Lot: AC-017114
- Exp. 11/24/2026
- AC-017164
- AC-017204
- AC-017205
- Exp. 12/31/2026.
Distribution
Distributed nationwide across the United States.
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