The Recall Desk
HighFDA (Food)·F-0427-2018·Announced 2017-12-13

FLAVORx Sweetening Enhancer Recalled for Microbial Growth

FLAVORx Inc. is recalling Sweetening Enhancer AQ bottles due to microbial growth detected during stability testing. The product is used as a pharmacy compounding material.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves microbial growth in a product used for pharmacy compounding. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

FLAVORx Inc. is recalling specific lots of FLAVORx Sweetening Enhancer AQ, a food additive used as a pharmacy compounding material. The recall was initiated after subsequent testing in the company's ongoing stability program indicated microbial growth in the product.

The affected product is packaged in amber glass Boston round bottles in 4oz and 1oz sizes. The specific lots involved are Lot #161269 with an expiration date of 12/2018, and Lot #170361 with an expiration date of 03/2019. The source text states that 24,600 bottles were distributed throughout the United States and two foreign countries.

Consumers and pharmacies should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be removed from use. The source text does not provide specific instructions for disposal or return, nor does it report any illnesses or injuries associated with the product.

The recalled product

Product
FLAVORx Sweetening Enhancer , the product is packaged as follows: "Sweetening Enhancer AQ, 4oz & 1oz Bottles, Lot #161269 / Exp. Date 12/2018 "Sweetening Enhancer AQ, 4oz & 1oz Bottles, Lot #170361 / Exp. Date 03/2019 #100 per box 1oz bottles, #50 per box 4oz bottles
Manufacturer
FLAVORx Inc.
Category
Food — Food Additive / Compounding Material
Hazard
Affected units
24,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • "Sweetening Enhancer AQ
  • 4oz & 1oz Bottles
  • Lot #161269 / Exp. Date 12/2018 "Sweetening Enhancer AQ
  • Lot #170361 / Exp. Date 03/2019

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by FLAVORx Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · FLAVORx Inc.

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Same hazard · microbial growth

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