The Recall Desk
ModerateFDA (Food)·F-0724-2022·Announced 2022-02-16

Caffeine vitamin supplement recalled for manufacturing process deviations

ULTRAtab Laboratories has recalled 1.6 million tablets of a caffeine and B-vitamin supplement due to manufacturing practice deviations. The bulk product was distributed to distributors in New York and Florida.

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 a Class II voluntary recall initiated by the manufacturer for manufacturing process deviations. The source does not mention any illnesses or injuries. Voluntary precautionary recalls for process compliance issues without reported harm are typically moderate severity.

Plain-English summary

ULTRAtab Laboratories, Inc. has recalled approximately 1.6 million tablets of Caffeine 150 mg with B6 and B12 vitamins supplement. The recall was initiated on October 6, 2021, due to deviations from current Good Manufacturing Practice (cGMP) requirements.

The affected bulk product was distributed to 2 distributors in New York and Florida, who may have repackaged and further distributed the product. The affected product codes are M961L with bulk lots 19E030 and 19E031.

Consumers who have purchased this product should discontinue use if they have product from the affected lot codes. The FDA has classified this as a Class II recall.

The recalled product

Product
Caffeine 150 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: M961L Bulk Lots: 19E030
  • 19E031

Distribution

Distributed in 2 states:

  • FL
  • NY

Related recalls

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