Apollo Care Recalls Semaglutide Vials Due to Particulate Matter
Apollo Care, LLC is recalling specific lots of Semaglutide 9mg 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter in an injectable drug, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Apollo Care, LLC is voluntarily recalling 24,608 vials of Semaglutide 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vials. The recall is due to the presence of particulate matter, which has been identified as nylon/polyamide and silk/proteinaceous-type material. The affected product is distributed nationwide within the U.S.
The recall includes vials with the following lot numbers and expiration dates: AC-017125 (Exp. 8/30/2026); AC-017138, AC-017147, AC-017214, AC-017226, and AC-017228 (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 is found, it should be discontinued and returned to the supplier or disposed of according to local regulations. Patients should contact their healthcare provider for alternative treatment options if they have been using the affected product.
The recalled product
- Product
- SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02
- Manufacturer
- Apollo Care, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 24,608
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 (8)
- Lot: AC-017125
- Exp. 8/30/2026
- AC-017138
- AC-017147
- AC-017214
- AC-017226
- AC-017228
- Exp. 12/31/2026.
Distribution
Distributed nationwide across the United States.
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