Food, drugs, devices › Medtech Products, Inc.
Drug recall: Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little Remedies Infant Feve
Medtech Products, Inc. (Tarrytown, NY) initiated this drug recall on 7 Mar 2019; FDA lists 1 product record under event 82333, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 68% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 18 Nov 2020. Initiation: voluntary: firm initiated. Medtech Products, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medtech Products, Inc., Tarrytown, NY.
Reason for recall
"Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit."
Distribution
"Nationwide in the United States."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1012-2019 | 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,… | 4,716 kits | Class II | Terminated | 20 Mar 2019 |
Context
Other enforcement events for Medtech Products, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 26 Jul 2019 | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) | Drug | Class II | 14 |
| 21 May 2015 | SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 190 | Drug | Class II | 1 |
| 10 Apr 2015 | MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per cas | Drug | Class III | 1 |
| 20 Jun 2012 | Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvi | Drug | Class II | 1 |
All 5 events for Medtech Products, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the United States."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Nov 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.