CLASS II Drug recall · Reported 12 Mar 2014 · FDA Enforcement Report
Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg recalled
Natures Pharmacy & Compounding Center is recalling Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg, distributed in North Carolina. The recall was initiated on 1 Nov 2013 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-1109-2014
- FDA event ID
- 66856
- Recalling firm
- Natures Pharmacy & Compounding Center, Asheville, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Nov 2013
- FDA classified
- 4 Mar 2014
- Reported
- 12 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Hormones & Birth Control
Timeline
| 1 Nov 2013 | Recall initiated by company | |
| 4 Mar 2014 | Classified by FDA | +123 days |
| 12 Mar 2014 | 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 Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
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
Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg
Where it was distributed
NC
Questions about this recall
Why was it recalled?
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Which lots are affected?
All lot numbers within expiry.
Where was it sold?
NC
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 21 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
47 other products · FDA event 66856This product is part of a recall event; the main page for the event is Papaverine 1nj 30mg/ml recalled by Natures Pharmacy &.