PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is voluntarily recalling PEPTIME Energy (caffeine 350mg) tablets due to cGMP (current good manufacturing practice) deviations. The recall affects 113,040 packets and 7,132 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): 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: This is an FDA Class II recall involving manufacturing practice deviations (cGMP violations). The source text does not report any illnesses, injuries, or deaths associated with the product, and the hazard is related to compliance with manufacturing standards rather than a direct safety threat. Per the rubric, Class II recalls without reported harm typically fall in the Moderate range.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling PEPTIME Energy (caffeine 350mg) tablets packaged in 6-count packets (Lot #19E032) and 100-count bottles (Lot #19E033). The product is marketed by DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., based in Noblesville, Indiana.
The recall was initiated due to cGMP (current good manufacturing practice) deviations in the manufacturing process. The affected products were distributed nationwide within the United States.
Consumers who have purchased PEPTIME Energy tablets should stop using the product. The FDA classified this as a Class II recall. The recall was initiated on January 24, 2022, and terminated on October 16, 2023.
The recalled product
- Product
- PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Supplement / OTC
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)
- Lot #: a)19E032
- b)19E033
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Ultra Seal Corporation under a single FDA (Drugs) 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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