Caffeine vitamin supplement tablets recalled for manufacturing deviations
ULTRAtab Laboratories is voluntarily recalling 1,393,353 caffeine supplement tablets due to manufacturing practice deviations.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: FDA Class II voluntary recall for manufacturing deviations. No specific contamination or illness is mentioned in the source.
Plain-English summary
ULTRAtab Laboratories, Inc. is recalling 1,393,353 tablets of its Caffeine 175 mg supplement product containing B6 and B12 vitamins. The recall was initiated on October 6, 2021, due to Current Good Manufacturing Practice (cGMP) deviations identified in the production process.
The bulk product was distributed to 2 distributors located in New York and Florida, who may have repackaged and further distributed the finished product. This recall was classified by the FDA as Class II and was terminated on September 1, 2022.
Consumers who have purchased this product should stop using it and contact ULTRAtab Laboratories for further information about the recall.
The recalled product
- Product
- Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 1,393,353
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: M962L Bulk Lots: 19E032
- 19E033
Distribution
Part of a larger recall action
This product is one of 9 recalled by ULTRAtab Laboratories, 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.
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