Though the presence of aluminum in certain products—specifically antiperspirants—has been a concern in recent years as researchers have investigated a potential cancer association, experts at the Ohio State University Wexner Medical Center state previous research has shown there is “no correlation between aluminum-containing antiperspirants and increased cancer risk, specifically breast cancer.”
Still, this week a nationwide recall alert from the U.S. Food and Drug Administration (FDA), announced publicly on Friday morning, indicates aluminum may have recently shown up unexpectedly in a heart medication.
The agency’s report reveals that a total of 11,328 bottles of 25-milligram Spironolactone Tablets are under recall across the country. Spironolactone is a generic for name brands such as Aldactone and CaroSpir, which are primarily used to treat high blood pressure and heart failure, according to the Cleveland Clinic. Both the Mayo and Cleveland Clinics report the drug can also reduce fluid retention related to the following conditions:
- Heart disease
- Kidney disease
- Liver disease
As a diuretic, the medication “prevents your body from absorbing too much salt and keeps your potassium levels from getting too low,” notes the Mayo Clinic.
The FDA reports “Presence of foreign substance: identified as aluminum” led to the recall. Regarding the inclusion of aluminum in current oral products, a previously released public health statement by the Agency for Toxic Substances and Disease Registry states: “Although aluminum-containing over the counter oral products are considered safe in healthy individuals at recommended doses, some adverse effects have been observed following long-term use in some individuals.”
It is not clear from the current FDA report how the aluminum’s presence was discovered or how much of the substance was potentially involved.
The report offered the following product details:
- Spironolactone Tablets, USP, 25 milligram (mg)
- 100-count bottle
- Rx only
- Lot #: P3314
- Expiration Date: 11/30/2026
- Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124
- Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
- National Drug Code (NDC): 53489-143-01
The report states the recall was first initiated August 5, then quickly assigned on August 7 with a Class II categorization. The FDA considers Class II recalls to be situations “in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
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