Apollo Care Recalls Semaglutide Vials Due to Particulate Matter
Apollo Care, LLC is recalling specific lots of Semaglutide 20mg 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 FDA classified this recall as Class II. Per the rubric, an FDA Class II recall involving a sterile injectable product with particulate matter is assigned a score of 4 (Severe) due to the potential for significant injury or adverse health consequences.
Plain-English summary
Apollo Care, LLC is voluntarily recalling 4,250 vials of Semaglutide 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vials. The recall is due to the presence of particulate matter identified as nylon/polyamide and silk/proteinaceous-type material. The affected product is prescription-only and intended for subcutaneous injection.
The recalled product is distributed nationwide within the U.S. The specific lots affected are AC-017275 (Expiration 12/13/2026), AC-017282, and AC-017285 (Expiration 12/27/2026). The NDC number for the product is 71170-724-04.
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 situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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.
- Manufacturer
- Apollo Care, LLC
- Category
- Drug — Injectable
- Affected units
- 4,250
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 (5)
- Lot: AC-017275
- Exp. 12/13/2026
- AC-017282
- AC-017285
- Exp. 12/27/2026.
Distribution
Distributed nationwide across the United States.
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