The Recall Desk
ModerateFDA (Food)·F-0723-2022·Announced 2022-02-16

Caffeine dietary supplement recalled due to manufacturing practice deviations

ULTRAtab Laboratories' caffeine and vitamin B-complex supplement is being recalled due to cGMP (Good Manufacturing Practice) deviations. The voluntary recall affects approximately 1,904,760 tablets distributed to wholesalers.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II voluntary recall with no reported illnesses or injuries. The hazard is a manufacturing process deviation without confirmed contamination or harm, fitting the category of precautionary recalls warranting a moderate severity level.

Plain-English summary

ULTRAtab Laboratories, Inc. of Highland, New York is recalling its Caffeine 125 mg with B6 and B12 vitamins supplement due to Good Manufacturing Practice (cGMP) deviations. Approximately 1,904,760 tablets are affected, identified by product code M960L and bulk lots 19E021 and 19E022.

The recall was initiated voluntarily by the manufacturer on October 6, 2021, and was classified as Class II by the FDA on February 9, 2022. The deviations relate to manufacturing processes and procedures.

Bulk product was distributed to two distributors in New York and Florida, who may have repackaged and further distributed the finished product. Consumers who have purchased this supplement should verify the product code and lot number and consult with their healthcare provider if concerned about products already consumed.

The recall was terminated on September 1, 2022.

The recalled product

Product
Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Manufacturer
ULTRAtab Laboratories, Inc.
Category
Food — Dietary Supplement
Hazard
  • manufacturing-deviation

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 (2)

  • Product Codes: M960L Bulk Lots: 19E021
  • 19E022

Distribution

Distributed in 2 states:

  • FL
  • NY

Related recalls

Same category