Drug Recall: PEPTIME Energy Caffeine Tablets cGMP Violations
Ultra Seal Corporation is recalling PEPTIME Energy 300mg caffeine tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 131,112 packets and 8,064 bottles distributed across the United States.
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 deviations. The source text does not report any illnesses, injuries, or hospitalizations, and the recall is based on process compliance issues rather than documented harm. Per the rubric, Class II recalls without reported illness typically fall in the Moderate range.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling PEPTIME Energy caffeine tablets (300mg) packaged in both 6-count packets (Lot #19E030) and 100-count bottles (Lot #19E031) due to current Good Manufacturing Practice (cGMP) deviations. The product is marketed by DMD Pharmaceuticals, a division of Dickery Consumer Products, Inc., based in Noblesville, Indiana.
Approximately 131,112 packets and 8,064 bottles have been distributed nationwide within the United States. The FDA classified this as a Class II recall.
Consumers who have purchased PEPTIME Energy tablets from the affected lots should stop use and consult their healthcare provider with questions. The recalling firm initiated this recall on January 24, 2022, and the recall was terminated on October 16, 2023.
The recalled product
- Product
- PEPTIME Energy (caffeine 300mg) 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
- Hazard
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)19E030
- b)19E031
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.
See all 56 products in this recall →Related recalls
Same manufacturer · Ultra Seal Corporation
See all →- ModeratePEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateExaprin Pain Reliever Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateCold Terminator decongestant recalled for cGMP deviations
FDA (Drugs) · 2022-02-09
- ModerateLite Remfresh Melatonin Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateExtra Strength Un-Aspirin Acetaminophen Packets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
Same hazard · cGMP violation
See all →- HighHand Sanitizer Recalled Due to Manufacturing Practice Deviations
FDA (Drugs) · 2023-02-08
- ModeratePyrogenium Homeopathic Remedy Recalled for Manufacturing Process Violations
FDA (Drugs) · 2022-06-22
- ModerateDrug Recall: PAINAID Tablets for Manufacturing Deviations
FDA (Drugs) · 2022-02-09
- ModerateCalvin Scott Recalls Diethylpropion Tablets Due to Stability Deviations
FDA (Drugs) · 2020-10-14
- ModerateCalvin Scott Recalls Phentermine Capsules Due to Stability Study Deviations
FDA (Drugs) · 2020-10-14
Similar recalls
- ModerateDBI Magnums Caffeine Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2022-02-16
- SeverePerrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination
FDA (Drugs) · 2020-03-25
- ModeratePeppermint Antacid Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2022-02-16
- ModerateBasic Reset Recalls Vibrant Energy Drink Pouches for CGMP Violations
FDA (Food) · 2019-11-27
- ModerateGlimepiride 2 mg Tablets Recalled for Manufacturing Quality Deviations
FDA (Drugs) · 2023-04-12
- ModeratePain Aid PMF Caplet Drug Recall for CGMP Deviations
FDA (Drugs) · 2022-02-16