Hyland's Baby Teething Tablets Recall: Inconsistent Belladonna Alkaloids
Standard Homeopathic Company recalls Hyland's Baby Teething Tablets due to inconsistent belladonna alkaloid levels that may differ from label claims. All affected products contain specific NDC and UPC numbers.
Lower-risk recall
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
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What happened, in plain English
Standard Homeopathic Company is recalling Hyland's Baby Teething Tablets because FDA analysis found inconsistent amounts of belladonna alkaloids. This could mean the actual drug content differs from what's labeled, potentially causing unintended effects in infants. Read more at govinfonow.com/recall/41755-hyland-s-baby-teething-tablets-recall-inconsistent-belladonna-alkaloids.
Source Summary by GovInfoNow · govinfonow.com/recall/41755-hyland-s-baby-teething-tablets-recall-inconsistent-belladonna-alkaloids · Updated October 8, 2026 · FDA enforcement record: FDA #D-0863-2017
Cite this page
“Hyland's Baby Teething Tablets Recall: Inconsistent Belladonna Alkaloids.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41755-hyland-s-baby-teething-tablets-recall-inconsistent-belladonna-alkaloids. Based on FDA recall #D-0863-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0863-2017%22&limit=1).
Why it’s dangerous
The tablets contain belladonna alkaloids, which can cause side effects like dizziness or nausea if the concentration differs from the label. Inconsistent levels may lead to unexpected effects in infants who take the product.
Who’s affected
Parents and caregivers of infants who use Hyland's Baby Teething Tablets. Infants are at higher risk due to the potential for inconsistent drug levels.
How to tell if you have this one
Check for 40-count, 135-count, or 250-count bottles with specific NDC numbers (54973-3127-1, 54973-3127-2, 54973-3127-3) and UPC codes listed in the recall notice.
- Brand
Hyland's- Product
Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Nationwide in the USA and Puerto Rico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0863-2017 | 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 bottles (NDC 54973-3127-1) (UPCs 3 54973 31271 5, 3 54973 31371 2, 3 54973 31481 8); and 250-count bottles (NDC 54973-3127-2) (UPCs 3 54973 31272 2, 3 54973 31521 1), Manufactured for: Hyland's, Inc., Los Angeles, CA 90061.; All lots within expiry | 10,263,585 bottles |
| D-0864-2017 | 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 bottle, Manufactured for: Hyland's, Inc., Los Angesles, CA 90061, NDC 54973-3197-1, UPC 3 54973 31971 4.; All lots within expiry | 692,115 bottles |
What to do — step by step
Check Product Details
Look for the NDC numbers 54973-3127-1, 54973-3127-2, or 54973-3127-3 on the bottle to confirm if the product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0863-2017 (April 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0863-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.