Drug Recall: Acetaminophen Phenylephrine Tablets for CGMP Deviations
ULTRAtab Laboratories is recalling Coated APAP 325 mg Phenylephrine HCl 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects bulk product 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 with no reported illnesses or injuries stated in the source text. The hazard is procedural/manufacturing-related rather than a direct product defect, and no adverse health outcomes are documented, placing it in the Moderate category.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling Coated APAP 325 mg Phenyl HCl 5 mg tablets (Acetaminophen 325 mg, Phenylephrine HCl 5 mg) in bulk containers. The recall involves 14,566,510 tablets with NDC 62959-134-00 and includes product code C134LC and bulk lots 18K055, 18M081, 19A097, 19B024, 19C054, 19E092, 19G094, and 19J042.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors, who may have distributed finished product to additional customers.
The FDA classified this recall as Class II on February 9, 2022. The firm initiated the recall on January 26, 2022, and the recall was terminated on January 7, 2025. Consumers or healthcare providers who have received this product should contact their supplier or ULTRAtab Laboratories for further instructions.
The recalled product
- Product
- Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Hazard
- manufacturing-deviation
- cgmp-violation
Distribution
Distribution scope not specified by the agency.
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