CLASS II Drug recall · Reported 25 Nov 2015 · FDA Enforcement Report
Progesterone 100 mg/mL in Corn Oil Injection vials recalled
Kalman Health & Wellness is recalling Progesterone 100 mg/mL in Corn Oil Injection vials, distributed nationwide in the US. The recall was initiated on 3 Sep 2015 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-321-2016
- FDA event ID
- 72241
- Recalling firm
- Kalman Health & Wellness, Peoria, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Sep 2015
- FDA classified
- 17 Nov 2015
- Reported
- 25 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 3 Sep 2015 | Recall initiated by company | |
| 17 Nov 2015 | Classified by FDA | +75 days |
| 25 Nov 2015 | 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
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Which lots are affected?
Lot #: 072915, Exp 10/29/2015
Where was it sold?
Nationwide
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
38 other products · FDA event 72241More recalls from Kalman Health & Wellness
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylcobalamin 30 mg/mL PF Injection prefilled syringes recalled | Kalman Health & Wellness | Sterility | Nationwide |
| Drug | CLASS II | Trimix Special (30 mg-1 mg-10 mcg/mL) Injection vials recalled | Kalman Health & Wellness | Sterility | Nationwide |
| Drug | CLASS II | HCG/mL Injection vial recalled by Kalman Health & Wellness | Kalman Health & Wellness | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin 1 mg/mL (Pres Free) Injection prefilled syringes recalled | Kalman Health & Wellness | Sterility | Nationwide |
| Drug | CLASS II | Acetylcysteine 10% Oph Solution recalled by Kalman Health & Wellness | Kalman Health & Wellness | Sterility | Nationwide |
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 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 |