Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Mar 7, 2019 (8 years ago)

Little Remedies New Baby Essentials Kit. Each kit contains 1 each…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.

Cause type: Chemical / undeclared

A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.

What 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.

Drug: Acetaminophen Category: Pain Relief & OTC Medication

Recalling firm
Medtech Products, Inc.
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1012-2019 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

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