The Recall Desk
ModerateFDA (Drugs)·D-0501-2022·Announced 2022-02-09

PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations

Ultra Seal Corporation is recalling PEPTIME Energy 250mg caffeine tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 100-count bottles distributed in the United States.

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 recall for cGMP deviations with no reported illnesses or injuries. cGMP violations are manufacturing-process issues representing a potential (not actual) health risk. The recall is voluntary and precautionary in nature, consistent with a Moderate severity rating.

Plain-English summary

Ultra Seal Corporation is recalling PEPTIME Energy caffeine tablets (250mg) sold in 100-count bottles and marketed by DMD Pharmaceuticals, a division of Dickery Consumer Products, Inc., located in Noblesville, Indiana. The recall affects products distributed nationwide within the United States.

The recall was initiated due to current good manufacturing practice (cGMP) deviations. The affected lots are 19E021 and 19E022. This is a voluntary recall initiated by the firm, and the FDA classified it as a Class II recall.

Consumers who have purchased PEPTIME Energy tablets from the affected lots should stop using the product. For questions or additional information, consumers may contact the recalling firm or the FDA.

The recalled product

Product
PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
Manufacturer
Ultra Seal Corporation
Hazard
  • cgmp-deviation
  • manufacturing-defect

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 #: 19E021
  • 19E022

Distribution

Distributed nationwide across the United States.