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.
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 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…
- 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
Other drug recalls
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- ModerateZoladex Goserelin Implant Recalled Due to Temperature Abuse
FDA (Drugs) · 2026-10-07
- ModerateAjanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
Similar recalls
- ModerateWest-ward Recalls Belladonna Alkaloids Tablets Due to Foreign Substance
FDA (Drugs) · 2013-03-06
- LowMylan Recalls Fexofenadine HCl Tablets Due to Impurity Failures
FDA (Drugs) · 2015-04-15
- LowMylan Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Levels
FDA (Drugs) · 2015-05-27
- SevereAurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23
- SevereMylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2018-12-19
- ModerateMylan Recalls Fexofenadine Tablets Due to Elevated Impurities
FDA (Drugs) · 2019-02-06