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Class III: unlikely to cause harmTerminated

ActiPharma ACTIRON Dietary Supplement Recall

ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309,…

ActiPharma, Inc. · Guaynabo, PR

Risk level
Class III
Reported by FDA
Nov 29, 2023
Recall ID
F-0463-2024
Check your lot numberHow we source this data

Summary

ActiPharma recalled ACTIRON Dietary Supplement starting Sep 28, 2023. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report F-0463-2024 on Nov 29, 2023. Reason: FDA sample analysis of ACTIRON Dietary Supplement, 100 Tablets, Lot 13309, found the product did not meet folic acid specification compared to the label claim. Status: Terminated.

Why it was recalled

FDA sample analysis of ACTIRON Dietary Supplement, 100 Tablets, Lot 13309, found the product did not meet folic acid specification compared to the label claim.

Product description

ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.

Lot numbers, UPCs & expiration codes

Lot 13309, Exp: 01/26

Where it was sold

Domestic distribution, in Puerto Rico.

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-0463-2024
Classification
Class III
Status
Terminated
Recall initiated
Sep 28, 2023
FDA report date
Nov 29, 2023
Quantity
607 bottles of 100 tablets each
Recall type
Voluntary: Firm initiated
Recalling firm
ActiPharma, Inc.

Original FDA data

Every field from FDA enforcement report F-0463-2024, exactly as published.

Show all FDA fields
City
Guaynabo
State
PR
Status
Terminated
Country
United States
Event ID
93210
Address
Carretera No. 1, Km. 21.1
Address (line 2)
Sector La Muda
Code information
Lot 13309, Exp: 01/26
Postal code
00971
Report date
Nov 29, 2023
Product type
Food
Recall number
F-0463-2024
Classification
Class III
Recalling firm
ActiPharma, Inc.
Product quantity
607 bottles of 100 tablets each
Termination date
Jan 16, 2024
Reason for recall
FDA sample analysis of ACTIRON Dietary Supplement, 100 Tablets, Lot 13309, found the product did not meet folic acid specification compared to the label claim.
Voluntary / mandated
Voluntary: Firm initiated
Product description
ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.
Distribution pattern
Domestic distribution, in Puerto Rico.
Recall initiation date
Sep 28, 2023
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Nov 17, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0463-2024, published Nov 29, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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