Phenylephrine HCl 5 mg Tablet Recall Due to CGMP Deviations
ULTRAtab Laboratories is recalling Phenylephrine HCl 5 mg tablets in bulk containers due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 4.5 million tablets distributed to three distributors.
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 CGMP deviations. No illnesses or injuries are reported in the source text, and the hazard is manufacturing process-related rather than a direct safety threat. Per the rubric, Class II recalls without reported hospitalization are typically scored as 2 (Moderate).
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling Phenylephrine HCl 5 mg Tablet bulk containers (NDC 62959-333-00, Product Code M333, Bulk Lots 18M065 and 19J078) totaling approximately 4,531,580 tablets.
The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. The bulk product was distributed to three distributors, who may have further distributed finished products to other customers.
The FDA classified this as a Class II recall and the firm initiated the recall voluntarily. Consumers or healthcare providers who have received products from this recall should contact their distributor or ULTRAtab Laboratories for instructions on return or disposal. The recall was terminated as of January 7, 2025.
The recalled product
- Product
- Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Drug — Tablet
- Affected units
- 4,531,580
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: M333 Bulk Lots: 18M065
- 19J078
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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