Class IIICompleted · reported 2026-02-11

OptiWize Health OptiWize Collagen Plus 320 count bottle; White bottle with black lid.

Optiwize Inc. recalled this product and the FDA reported the enforcement action on 11 February 2026 as Class III. The recall was initiated by the firm. The firm initiated a voluntary recall after NSF testing showed that labeled ingredient quantities did not align with analytical test results, manganese level was below label quantity.

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product: OptiWize Health OptiWize Collagen Plus 320 count bottle; White bottle with black lid.
Reason for recall: The firm initiated a voluntary recall after NSF testing showed that labeled ingredient quantities did not align with analytical test results, manganese level was below label quantity.
Recalling firm: Optiwize Inc.
Firm location: Buda, Texas, United States
Classification: Class III
Status: Completed
Recall number: H-0442-2026
Quantity: 78 units
Distribution: Nationwide via Amazon distribution
Initiated: 23 September 2025
Reported by FDA: 11 February 2026
Firm notified by: E-Mail
Product codes: OHB25230

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
This record is the only one the FDA opened for its recall event, so it covers a single product code.
This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
The FDA published the enforcement report 5 months after the firm began the recall.
The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

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Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.