What happened
Original notice title
M.O.M. Enterprises, LLC MARCS-CMS 698651, April 22, 2025
From the archived source record
Based on inspectional findings and a review of your product labels collected during the inspection, as well as a review of your firm’s website, www.mommysbliss.com, we identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Adulterated Dietary Supplements The inspection of your facility from August 19 through September 27, 2024, identified serious violations of FDA’s regulations for current Good Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21 of the Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplement products Gripe Water Original, Gripe Water Night Time, Kids Cough Syrup & Mucus + Immunity Support, and Kids Cough Syrup & Mucus Night Time (including such product in the Day + Night Combo Packs) to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet cGMP requirements for dietary supplements. Your significant violations of the cGMP requirements are as follows: 1. The product has since reformulated the product [ sic ].” Your investigation, however, does not explain how such reformulation would have addressed the issue relating to bulging product bottles and product packaging that popped open, nor did it address the concerns relating to this specific lot that had not been withdrawn from the market. For example, our inspection found you received reports of infants choking, infants that stopped breathing, and infants that were admitted to the hospital after being administered your Gripe Water Original products. The complainant explained they called the local emergency room which advised the complainant to bring the baby to the hospital.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 2fe2f50cba0a
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →