Hyland's Baby Nighttime Teething Tablets Recalled for Inconsistent Belladonna Alkaloids
Standard Homeopathic Company is recalling Hyland's Baby Nighttime Teething Tablets because FDA analysis found inconsistent amounts of belladonna alkaloids.
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 severity score of 5 according to the rubric.
Plain-English summary
Standard Homeopathic Company is recalling Hyland's Baby Nighttime Teething Tablets, 135-count bottles, due to inconsistent amounts of belladonna alkaloids. The FDA analysis determined that the actual amounts of these alkaloids may differ from the calculated amounts listed on the product labels.
The recall involves 692,115 bottles of the product, which were distributed nationwide in the USA and Puerto Rico. The product is identified by NDC 54973-3197-1 and UPC 3 54973 31971 4. All lots within the expiry date are affected.
Consumers should stop using the recalled product and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottl
- Manufacturer
- Standard Homeopathic Company
- Category
- Drug — Homeopathic
- Affected units
- 692,115
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 Teething Tablets Recalled for Inconsistent Belladonna Alkaloid Levels
FDA (Drugs) · 2017-05-31
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