Apollo Care Recalls Semaglutide Vials Due to Particulate Matter
Apollo Care, LLC is recalling 9,762 vials of Semaglutide 4.5mg due to the presence of 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. Per the rubric, FDA Class II recalls are mapped to a score of 4 (Severe), particularly given the risk of injecting particulate matter into the body.
Plain-English summary
Apollo Care, LLC is voluntarily recalling 9,762 vials of Semaglutide 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vials. The recall was initiated because the product was found to contain particulate matter identified as nylon/polyamide and silk/proteinaceous-type material.
The affected product is prescription-only and intended for subcutaneous injection. The recall covers lots AC-017124 (expiring 8/30/2026) and AC-017136 (expiring 12/31/2026). The product was distributed nationwide within the United States.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03
- Manufacturer
- Apollo Care, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 9,762
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 (4)
- Lot: AC-017124
- Exp. 8/30/2026
- AC-017136
- Exp. 12/31/2026.
Distribution
Distributed nationwide across the United States.
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