On October 23, 2010, Standard Homeopathic Company, in consultation with the Food and Drug Administration, issued a voluntary recall of its Hyland Teething Tablets. The company is going forward with the recall as a cautionary measure due to an FDA investigation of its manufacturing facility.
As listed in the press release from the FDA, the following UPC codes are included in the recall:
1. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75041
2. Hyland’s Teething Tablets, 250 tablets, UPC # 3 54973 75042
3. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75066
4. Hyland’s Teething Tablets, 50 tablets, UPC # 3 54973 75044
5. Hyland’s Teething Tablets, 145 tablets, UPC # 3 54973 75121
6. Hyland’s Teething Tablets, Clip Strip 6x125 tablets, UPC # 3 54973 35109
There have been some adverse events have been reported but the FDA has not determined a conclusive link to the Hyland’s tablets. The company is working with the FDA to identify manufacturing improvements and uniformity in dosing.
Hyland’s teething tablets contain the ingredient belladonna. Belladonna is a homeopathic agent that helps relieve teething symptoms but if taken in large doses can have serious side effects. The Standard Homeopathic Company maintains that its products are safe but they are working with the FDA to ensure the continued safety of its consumers.
Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.