CLASS II Drug recall · Reported 20 Mar 2019 · FDA Enforcement Report
Little Remedies New Baby Essentials Kit recalled by Medtech Products
Medtech Products is recalling Little Remedies New Baby Essentials Kit, distributed nationwide in the US. The recall was initiated on 7 Mar 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1012-2019
- FDA event ID
- 82333
- Recalling firm
- Medtech Products, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Mar 2019
- FDA classified
- 20 Mar 2019
- Reported
- 20 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Pain Medication
Timeline
| 7 Mar 2019 | Recall initiated by company | |
| 20 Mar 2019 | Classified by FDA | +13 days |
| 20 Mar 2019 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the United States.
Questions about this recall
Why was it recalled?
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Which lots are affected?
Kit Lot #: 8473AG, 8473AI, Exp. 08/2020
Where was it sold?
Nationwide in the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtech Products
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display recalled | Medtech Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clear eyes Maximum Itchy Eye Relief (Glycerin recalled | Medtech Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clear Eyes Redness Relief Hand Pocket Pal Tray Display recalled | Medtech Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clear eyes Maximum Redness Relief (Glycerin recalled by Medtech Products | Medtech Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clear eyes Redness Relief (Glycerin recalled by Medtech Products | Medtech Products | Manufacturing (CGMP) Deviations | Nationwide |