Hyland's Baby Teething Tablets Recalled for Inconsistent Belladonna Alkaloid Levels
Standard Homeopathic Company is recalling Hyland's Baby Teething Tablets because FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from label claims.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4, but the presence of a superpotent drug with inconsistent toxic alkaloid levels in a product for infants elevates the risk to Critical (5) per the rubric's criteria for serious injury potential.
Plain-English summary
Standard Homeopathic Company is voluntarily recalling Hyland's Baby Teething Tablets, quick-dissolving tablets packaged in 40-count, 135-count, and 250-count bottles. The recall covers 10,263,585 bottles distributed nationwide in the USA and Puerto Rico. All lots within expiry are affected.
The FDA initiated this recall after analysis revealed inconsistent amounts of belladonna alkaloids in the product. These levels may differ from the calculated amount stated on the product labels, classifying the product as a superpotent drug. Belladonna alkaloids are toxic substances, and inconsistent dosing poses a safety risk.
Consumers should stop using the recalled tablets immediately. They should return the product to the place of purchase for a refund or contact Standard Homeopathic Company for further instructions. The product is manufactured for Hyland's, Inc., Los Angeles, CA.
The recalled product
- Product
- Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bo
- Manufacturer
- Standard Homeopathic Company
- Category
- Drug — Homeopathic Medication
- Affected units
- 10,263,585
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry
Distribution
Part of a larger recall action
This product is one of 2 recalled by Standard Homeopathic Company under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Standard Homeopathic Company
See all →- CriticalHyland's Baby Nighttime Teething Tablets Recalled for Inconsistent Belladonna Alkaloids
FDA (Drugs) · 2017-05-31
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