FLAVORx Sweetening Enhancer Recalled for Microbial Growth
FLAVORx Inc. is recalling specific lots of Sweetening Enhancer used in pharmacy compounding due to microbial growth detected in stability testing.
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. The hazard involves microbial growth in a product used for pharmacy compounding, which poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
FLAVORx Inc. is recalling specific lots of FLAVORx Sweetening Enhancer, 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 as Fillmaster Auto Sweetening Enhancer AQ in 4oz amber glass Boston round bottles. The recall covers 420 bottles across six specific lots: #3281712 (Exp. 12/2018), #4281712 (Exp. 03/2019), #5181712 (Exp. 03/2019), #8151712 (Exp. 03/2019), #8311712 (Exp. 03/2019), and #9011712 (Exp. 03/2019).
The product was distributed throughout the United States and two foreign countries. The source text does not specify which foreign countries were affected or provide details on specific distribution channels. Consumers and pharmacy compounding facilities should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be discontinued from use and returned to the supplier or disposed of according to local regulations, as the source does not provide specific consumer instructions beyond the recall notice.
The recalled product
- Product
- FLAVORx Sweetening Enhancer , the product is packaged as follows: Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #3281712 / Exp. Date 12/2018 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #4281712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer
- Manufacturer
- FLAVORx Inc.
- Hazard
- Affected units
- 420
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 (8)
- Fillmaster Auto Sweetening Enhancer AQ
- 4oz Bottle
- Lot #3281712 / Exp. Date 12/2018 Fillmaster Auto Sweetening Enhancer AQ
- Lot #4281712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ
- Lot #5181712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ
- Lot #8151712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ
- Lot #8311712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ
- Lot #9011712 / 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.
See all →- HighFLAVORx Sweetening Enhancer Recalled for Microbial Growth
FDA (Food) · 2017-12-13
- HighFLAVORx Recalls Sweetening Enhancer Due to Microbial Growth
FDA (Food) · 2017-12-13
Same hazard · microbial growth
See all →- ModerateSysco Classic and Bay Valley Foods Thank You Chocolate Pudding Recall
FDA (Food) · 2025-06-11
- ModerateRed Shell Teriyaki Sauce Recall Due to Microbial Growth
FDA (Food) · 2025-04-16
- ModerateOzona Organics and Go Healthy Liquid Probiotics recalled for potential microbial growth
FDA (Food) · 2023-10-04
- HighROi CPS LLC Recalls Regard Dressing Change Trays Due to Microbial Growth
FDA (Devices) · 2021-05-19
- SevereReese Hollandaise Sauce Recalled Due to Compromised Vacuum Seals
FDA (Food) · 2021-02-17