CLASS II ONGOING Drug recall · Reported 15 Jan 2025 · FDA Enforcement Report
Progesterone Injection USP, 500mg per (50mg/mL) Multiple Dose Vial recalled
Eugia US is recalling Progesterone Injection USP, 500mg per (50mg/mL) Multiple Dose Vial, distributed nationwide in the US. The recall was initiated on 27 Dec 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-0186-2025
- FDA event ID
- 96073
- Recalling firm
- Eugia US, East Windsor, NJ
- Brand
- Progesterone
- Manufacturer
- Eugia US LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Dec 2024
- FDA classified
- 7 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Dec 2024 | Recall initiated by company | |
| 7 Jan 2025 | Classified by FDA | +11 days |
| 15 Jan 2025 | Published in enforcement report | +8 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: A market complaint was received of a glass piece in the vial.
Product as listed by the FDA
Progesterone Injection USP, 500mg 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
Distributed Nationwide in the USA.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Which lots are affected?
Batch # 1PR24010, Expiry: 02/28/2027
Where was it sold?
Distributed 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, 500 mg 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 |