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High RiskFDAfda-F-1295-2019UNDECLARED ALLERGEN

Addback Tablet Dietary Supplement 60 tablets per 190cc Oblong WHDPE bottle Net Wet: 85gm (60 tablet wt) UPC- 0651536124526 Firm n...

Category
Units Affected
2,095
Recall Date
March 29, 2019
Issuing Agency
Hazard
Undeclared Allergen

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-F-1295-2019.

Undeclared coating ingredients: HPMC, Triacetin, Titanium Dioxide, FD & C Yellow # 5, FD & C Yellow # 6, FD & C Blue # 1. In addition, the label states Silicon Dioxide, which is not part of the formulation

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-F-1295-2019.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Cays Llc or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-F-1295-2019.

Cays LLC

FDA

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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📣 Report a food, supplement, or cosmetic problem to the FDA

If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

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Cays Llc Recall FAQ

Cays Llc is the subject of a supplements safety report: Addback Tablet Dietary Supplement 60 tablets per 190cc Oblong WHDPE bottle Net Wet: 85gm (60 tablet wt) UPC- 0651536124526 Firm n.... The notice was published on March 29, 2019 by the U.S. Food and Drug Administration (FDA). Approximately 2,095 units are potentially affected.