The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0863-2017·Announced 2017-05-31

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.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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…
Manufacturer
Standard Homeopathic Company
Category
Drug — Homeopathic Medication
Hazard
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

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