Drug Recall: Phenylephrine HCl 5mg Tablets Bulk Container
ULTRAtab Laboratories is recalling approximately 7.9 million Coated Phenylephrine HCl 5mg tablets in bulk containers due to manufacturing process deviations that may affect product quality and safety.
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 a Class II FDA recall for CGMP deviations, which do not explicitly describe reported illnesses or serious injuries. The source text provides no evidence of harm reported. Under the rubric, Class II recalls without reported hospitalization or documented injury typically score as Moderate (2).
Plain-English summary
ULTRAtab Laboratories, Inc. is recalling Coated Phenylephrine HCl 5mg Tablets (Bulk Container) distributed under NDC 62959-338-00. The product identification includes lot codes M338 with bulk lots 19A070, 19B080, and 19J043. Approximately 7,983,360 tablets are affected by this recall.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility in Highland, NY. This is a voluntary recall initiated by the firm.
The bulk product was distributed to 3 distributors, who may have distributed finished products containing this material to downstream customers. The recall was announced on January 26, 2022, and classified by the FDA as a Class II recall on February 9, 2022. The recall was terminated on January 7, 2025.
Customers who have received this product should stop use and contact their supplier or ULTRAtab Laboratories for recall instructions. Healthcare providers and patients using finished products containing this material should consult with their healthcare provider.
The recalled product
- Product
- Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Hazard
- manufacturing-deviation
- cgmp-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 (3)
- Product Codes: M338 Bulk Lots: 19A070
- 19B080
- 19J043
Distribution
Distribution scope not specified by the agency.
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