Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported March 20, 2019
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
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Medtech Products, Inc. recalled Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following produc… - a moderate-severity action.
Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following produc… was recalled by Medtech Products, Inc. in March 20, 2019. Reason: Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained withi…. Check the official notice for the remedy. Verify recall #D-1012-2019 with the FDA Drug before acting.
The recall
Medtech Products, Inc. issued this moderate-severity FDA Drug recall-Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained withi….
- Moderate
- severity level
- Class II
- classification
- March 20, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1012-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1012-2019) was formally reported on March 20, 2019, with the manufacturer initiating the action on March 7, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtech Products, Inc. is listed as the recalling firm, operating out of Tarrytown, NY. Federal records list the affected scope as 4,716 kits.
The documented reason for this recall is: Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit. Distribution data in the federal record shows the product reached: Nationwide in the United States.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4,716 kits
Related Recalls
6
5 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1012-2019 |
| Date reported | March 20, 2019 |
| Date initiated | March 7, 2019 |
| Recalling firm | Medtech Products, Inc. |
| Firm location | Tarrytown, NY |
| Affected scope | 4,716 kits |
| Distribution | Nationwide in the United States. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1012-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtech Products, Inc.. Units affected: 4,716 kits.
Why was this product recalled? ▼
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 20, 2019. Severity: Moderate. Recall number: D-1012-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the United States..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1012-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 20, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.