CLASS II ONGOING Drug recall · Reported 19 Aug 2026 · FDA Enforcement Report
Semaglutide 4.5mg (0.9 mg/mL) Sterile Multi-Dose Vial recalled
Apollo Care is recalling Semaglutide 4.5mg (0.9 mg/mL) Sterile Multi-Dose Vial, distributed nationwide in the US. The recall was initiated on 29 Jul 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0750-2026
- FDA event ID
- 99505
- Recalling firm
- Apollo Care, Columbia, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jul 2026
- FDA classified
- 7 Aug 2026
- Reported
- 19 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Particulate Matter
- Drug class
- Diabetes Medication
Timeline
| 29 Jul 2026 | Recall initiated by company | |
| 7 Aug 2026 | Classified by FDA | +9 days |
| 19 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Product as listed by the FDA
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
Where it was distributed
Nationwide within the U.S
Questions about this recall
Why was it recalled?
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Which lots are affected?
Lot: AC-017124, Exp. 8/30/2026; AC-017136, Exp. 12/31/2026.
Where was it sold?
Nationwide within the U.S
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 99505This product is part of a recall event; the main page for the event is Semaglutide 7.5mg (5mg/mL), Glycine 7.5 mg recalled by Apollo Care.
More recalls from Apollo Care
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Semaglutide 5mg (1mg/mL), Glycine 25 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 9mg (4.5 mg/mL) Sterile Multi-Dose Vial recalled | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 10mg (5mg/mL), Glycine 10 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 20mg (5mg/mL), Glycine 20 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 0.9mg (0.9 mg/mL) Sterile Multi-Dose Vial recalled | Apollo Care | Particulate Matter | Nationwide |
Other Semaglutide recalls
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Semaglutide 5mg (1mg/mL), Glycine 25 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 9mg (4.5 mg/mL) Sterile Multi-Dose Vial recalled | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 10mg (5mg/mL), Glycine 10 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 20mg (5mg/mL), Glycine 20 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 0.9mg (0.9 mg/mL) Sterile Multi-Dose Vial recalled | Apollo Care | Particulate Matter | Nationwide |