Nearly 35,000 Estrogen Supplements Have Been Recalled Nationwide
Updated: Jun. 12, 2024
National authorities cite quality concerns with what they call an "Rx only" hormone replacement product manufactured outside the country.
There’s a certain level of assurance you feel when you get that prescription in hand for the hormone replacement supplement your doctor has prescribed. When a medical doctor determines this is an appropriate treatment, the patient probably looks forward to relief from both the obvious and insidious menopause symptoms, such as more reliable sleep, changes in the complexion, and even a less active bladder, not to mention the potential for trimming down and seeing key health metrics like cholesterol improve.
Estrogen, often referred to as “estradiol” in the clinical setting, is arguably the most commonly known hormone replacement intervention. Research has shown that in many cases, it’s also among the most helpful. Estrogen supplementation can be delivered via pills, topical gels or creams, injections, sprays, and patches; the last of which can eliminate some worry of forgetting to self-administer a dose.
However, the U.S. Food and Drug Administration, or the FDA, has announced the recall of 34,800 transdermal (topical skin) patches containing estrogen. Both are to be administered twice weekly, but the dosage amounts between the two differ.
Details to identify the recalled estrogen patches are as follows:
- Estradiol Transdermal System, USP
- 0.025mg/day (13,440 units recalled)
- Rx Only
- Manufactured by: Cadila Healthcare Limited, Ahmedabad, India
- Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
- NDC (National Drug Code): 70710-1191-8
- Lot number M311202 with Expiration Date of 2/25
- Lot number M311201 with Expiration Date of 1/25
- Estradiol Transdermal System, USP, 0.0375mg/day (21,360 units recalled)
- Rx Only
- Manufactured by: Cadila Healthcare Limited, Ahmedabad, India
- Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
- NDC (National Drug Code): 70710-1192-8
- Lot number M311202 with Expiration Date of 2/25
- Lot number M311201 with Expiration Date of 1/25
Distribution of both products is reportedly “nationwide within the United States.”
The cited reason for the recall is “failed impurities/degradation specifications.” A review of an FDA document on identifying drug impurities and degradations suggests either exposure to environmental factors such as light or extreme temperature may have affected the actual amount of estradiol in the product, factors may have caused another chemical change in the product, or simply an impurity “that is not the drug substance,” in this case estradiol, was found to be present.
After the recall was first initiated on May 16, this week the FDA categorized this as a Class III recall, which suggests they do not see exposure to this as life-threatening or extremely hazardous to consumers.
| What Each FDA Recall Classification Means | |
| Class I Recall | This is the most severe recall type, issued for products that could cause serious health issues or death. |
| Class II Recall | This type involves products that may cause temporary or medically reversible adverse health effects. |
| Class III Recall | This is for products that are unlikely to cause health problems but fail to comply with FDA labeling or manufacturing regulations. |
This follows last week’s report of a popular weight loss and diabetes drug that was also recalled following apparent nationwide distribution.
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Originally Published: June 12, 2024
