Little Remedies New Baby Essentials Kit — Class II drug recall D-1012-2019
Terminated recall by Medtech Products, Inc., reported 2019-03-20, distributed nationwide. Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within
| Recall number | D-1012-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtech Products, Inc., Tarrytown, NY, United States |
| Recall initiated | 2019-03-07 |
| Classified | 2019-03-20 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2020-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 4,716 kits |
| Reason classes | undeclared allergen, labeling |
| UPC / GTIN / UDI-DI | 00756184000076 |
| Lot numbers | 8473AG, 8473AI |
| Expiration dates | 2020-08 |
Product
Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little Remedies Infant Fever Reducer (acetaminophen 150mg) 2 fl. oz. bottle, Little Remedies Saline Spray/Drops (sodium chloride) 0.5 fl oz., Little Remedies Gripe Water (zingiber officinale (Ginger) Root Extract 5mg, Foeniculum vulgare (Fennel) Seed Extract 4 mg) 2 fl. oz bottle., Little Remedies Gas Relief Drops (simethicone emulsion USP 66.7 mg and simethicone 20 mg) 1 fl. oz., Boudreaux's Butt Paste (zinc oxide 16%) 2 oz. ointment,. Distributed by Medtech Products Inc. Tarrytown, NY, a Prestige Consumer Healthcare Company. UPC 7 56184 00007 6.
Reason for recall
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
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-1012-2019. 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.