Dologen 325 Caplet Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. has voluntarily recalled Dologen 325 Caplet bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 917,304 tablets that were 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: The recall is FDA Class II with no reported illnesses or injuries. CGMP deviations are manufacturing-quality issues that present a theoretical risk but do not meet the threshold for High severity, which requires either reported harm or high-risk pathogens.
Plain-English summary
ULTRAtab Laboratories, Inc. is recalling Dologen 325 Caplet (containing Acetaminophen 325 mg and Dexbrompheniramine Maleate 1.0 mg) in bulk container form. The product is identified by NDC 62959-121-00 and was manufactured in Highland, NY.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered during manufacturing. This is a voluntary recall initiated by the manufacturer on January 26, 2022, and was terminated on January 7, 2025.
The bulk product was distributed to 3 distributors, who may have further distributed finished product to retail or healthcare facilities. Affected product codes are C121L with bulk lot numbers 19G074 and 19G075.
Consumers or healthcare providers who have this product should contact their supplier or the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Hazard
- Affected units
- 917,304
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)
- Product Codes: C121L Bulk Lots: 19G074
- 19G075
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 33 recalled by ULTRAtab Laboratories, Inc. 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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