Drug Recall: PEPTIME Energy Tablets cGMP Deviations
Ultra Seal Corporation is voluntarily recalling PEPTIME Energy (caffeine 250mg) tablets distributed nationwide due to manufacturing practice deviations. The recall affects 156,096 packets and 9,648 bottles.
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 for manufacturing practice deviations (cGMP). The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is procedural rather than inherent to the product itself. Class II recalls without reported illness or injury typically warrant a Moderate severity score.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling PEPTIME Energy caffeine 250mg tablets distributed nationwide within the United States. The product is packaged in two formats: 6-count packets (Lot #19E021, approximately 156,096 packets) and 100-count bottles (Lot #19E022, approximately 9,648 bottles). The product is marketed by DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
The recall was initiated because of cGMP (current good manufacturing practice) deviations identified during manufacturing. The recall was initiated on January 24, 2022, classified as FDA Class II on January 31, 2022, and voluntarily undertaken by the manufacturing firm. The recall was terminated on October 16, 2023.
Consumers who have purchased affected lots should contact the manufacturer or their retailer for further instructions.
The recalled product
- Product
- PEPTIME Energy (caffeine 250mg) 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 — Caffeine supplement
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)19E021
- b)19E022
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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