Vitamin D Recall: By Now Foods

NOW Foods has implemented a recall on their calcium, magnesium and vitamin D softgel since the amount of D in the product was found to have 50 to 66 times the amount it claimed on the label.   The product had varying amounts of vitamin D from 30,000 International Units (IU's) to 40,000 IU's, much higher than the 800 IU's recommended by the Institute of Medicine.   Many of us who are D deficient have to take high doses of D to stabilize our 25 (OH) D levels, but this amount, used in NOW Foods formulas, is used by those whose levels are already at a normal level.  For those with normal circulating vitamin D levels would not take this high of a dose. Testing of the softgel was prompted by several Adverse Events Reporting claims, to the FDA, by consumers using this product.

Symptoms of high dietary intake of D are:   "weakness, fatigue, sleepiness, headache, loss of appetite, dry mouth, metallic taste, nausea, vomiting, abdominal cramps, constipation, diarrhea, dizziness, ringing in the ears, trouble walking, skin eruptions, muscle pain, bone pain and irritability. Advanced symptoms may include runny nose, itching, increased frequency of urination, nighttime awakening to urinate and thirst, according to Natural Products Insider. [1]

"The product was distributed throughout the United States and other countries. The affected U.S. product codes are 1251, 1252. The recall also affects private label products codes."   NOW Foods instituted a voluntary recall after receiving the reports from the FDA.   NOW Foods also mentions "Lelah noted NOW Foods tests this product for calcium and magnesium and has never had a problem, but he said it is difficult for any manufacturer to detect minor ingredients in complex mixtures."   "Standard methods of analysis using sophisticated HPLC technology don't work for vitamin D in a finished product because of matrix interference, so we would not have been able to identify this in our routine product testing." [1]

If you have this product in your household, report it to the company and the FDA.   You may also return the product to the manufacturer for reimbursement.

We all need to take adequate amounts of D, calcium and magnesium but we also have to have faith in the product we take and not find out that a huge mistake was made.

When we purchase our supplements, look for the USP mark on the label that will tell you the product is a verified supplement; but unfortunately there can always be mistakes made at the manufacturing process or testing level. Thanks to those who reported this through the AERS reporting service, at the FDA, or we may not have heard about this.

If you did take this product, it would be a good idea to have your vitamin D levels checked through a 25 (OH) D blood test to see if your scores have increased greatly.   If your scores are now suddenly much higher, than they were, discuss with your Dr. what you should do besides getting back on the correct dose for your personal vitamin D blood level score.

Keep in mind that the laboratory scores for normal D levels are greatly disputed by D experts who feel normal should be in the range of 60-80 ng/mL which is very different from our laboratories normal range.


NOW Foods Recalls Softgels for Excessive Vitamin D, June 8, 2011 authors: Natural Products Insider