Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS — Class I drug recall D-0864-2017
Terminated recall by Standard Homeopathic Company, reported 2017-05-31, distributed nationwide. Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the cal
| Recall number | D-0864-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Standard Homeopathic Company, Los Angeles, CA, United States |
| Recall initiated | 2017-04-13 |
| Classified | 2017-05-24 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2017-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 692,115 bottles |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 00354973319714 |
| NDC | 54973-3197-01 |
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 bottle, Manufactured for: Hyland's, Inc., Los Angesles, CA 90061, NDC 54973-3197-1, UPC 3 54973 31971 4.
Reason for recall
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0864-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.