GNC Women's 30+ Vitapak, Carton of 30 Sachets. Each sachet contains four tablets and a capsule. Paper-board carton that
Summary
The FDA issued a Class III for GNC Women's 30+ Vitapak, Carton of 30 Sachets. Each sachet contains four tablet by GNC Holdings LLC. Reason: Undeclared Fish allergen (parvalbumin)..
Details
Source
Food Recall
External ID
F-0928-2025
Action Date
2025-06-11
Status
Terminated
Category
food
Product Description
GNC Women's 30+ Vitapak, Carton of 30 Sachets. Each sachet contains four tablets and a capsule. Paper-board carton that measures 10.25 width x 3.56 height x 3.15 depth containing 30 sachets of 3 width x 2.75 height with tear notch. 15 Cartons per Case
Lot/Code Info: Lot No. 1060EB2401 1060EB2402 1060EB2403 1060EB2404 1060EB2405 1060EB2501 1060EB2502 1060EB2503
Quantity Affected: 144,430 Units
Reason for Recall
Undeclared Fish allergen (parvalbumin).
Distribution
The adulterated product was distributed to the various states: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-25
Company
Pittsburgh, PA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 123 food recalls issued in the same week, part of 204 food-related FDA actions this month.
GNC Holdings LLC has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GNC Holdings LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GNC Holdings LLC have FDA actions?
GNC Holdings LLC has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0928-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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