DBI Magnums Caffeine Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. is voluntarily recalling DBI Magnums Tablet (Caffeine 200 mg) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 8.7 million tablets distributed to three distributors.
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. The source text does not report any illnesses, injuries, or hospitalizations. CGMP deviations are manufacturing process violations that represent a potential for harm but do not indicate an immediate serious health risk without reported adverse events, placing this in the Moderate category per the rubric.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling DBI Magnums Tablet (Caffeine 200 mg) in multiple package configurations, including 100-count and 500-count bottles, 3-count and 36-count packets, and bulk containers (NDC 62959-941-00).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. Approximately 8,727,657 tablets are affected. The bulk product was distributed to three distributors, who may have distributed the finished product further.
Affected product codes are M941L and M940LA, with bulk lot numbers 19C065, 19F081, 19H083, and 17D088. Consumers or health care providers in possession of this product should contact ULTRAtab Laboratories, Inc. for instructions on return or disposal.
The recall was initiated on January 26, 2022, and classified as a Class II recall by the FDA on February 9, 2022. The recall was terminated on January 7, 2025.
The recalled product
- Product
- DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Drug — Caffeine Supplement
- Hazard
- cgmp-deviation
- manufacturing-process-violation
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 (4)
- Product Codes: M941L M940LA Bulk Lots: 19C065
- 19F081
- 19H083
- 17D088
Distribution
Distribution scope not specified by the agency.
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