CLASS II ONGOING Drug recall · Reported 7 Aug 2024 · FDA Enforcement Report
Progesterone Injection, USP, 500 mg per (50mg/mL) Multiple-Dose Vial recalled
Eugia US is recalling Progesterone Injection, USP, 500 mg per (50mg/mL) Multiple-Dose Vial, distributed nationwide in the US. The recall was initiated on 26 Jul 2024 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-0624-2024
- FDA event ID
- 95059
- Recalling firm
- Eugia US, East Windsor, NJ
- Brand
- Progesterone
- Manufacturer
- Eugia US LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jul 2024
- FDA classified
- 1 Aug 2024
- Reported
- 7 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Jul 2024 | Recall initiated by company | |
| 1 Aug 2024 | Classified by FDA | +6 days |
| 7 Aug 2024 | Published in enforcement report | +6 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: Complaint received of a glass particle in the vial.
Product as listed by the FDA
Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E Windsor, NJ 08520, NDC 55150-306-10.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Which lots are affected?
Lot #: CPR230029A
Where was it sold?
Nationwide in the USA
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.
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Other Progesterone recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Progesterone Injection USP, 500mg per (50mg/mL) Multiple Dose Vial recalledProgesterone | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS II | Progesterone 200 mg, Compounded, Rx recalled by Coast Quality Pharmacy | Coast Quality Pharmacy | Foreign Material | Nationwide |
| Drug | CLASS II | Progesterone 100mg/ML Inj # Ethyl Oleate Injectable recalled | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Progesterone 100mg/ML Mdv Oil Injection recalled | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | Progesterone Capsules, 200 mg recalled by Dr. Reddy's LaboratoriesProgesterone | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |