The Recall Desk
ModerateFDA (Drugs)·D-0529-2022·Announced 2022-02-16

APAP 325 mg/Phenylephrine HCl 5 mg Tablets Bulk Container Recall

ULTRAtab Laboratories is recalling approximately 451,123 APAP 325 mg/Phenylephrine HCl 5 mg tablets in bulk containers due to CGMP deviations. The product was distributed to three distributors for further distribution as finished goods.

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 recall with no reported illnesses or injuries. The hazard identified is a manufacturing practice deviation rather than a direct safety hazard with immediate health consequences. Class II recalls with no reported harm typically score 2 per the rubric.

Plain-English summary

ULTRAtab Laboratories, Inc., located in Highland, New York, is recalling APAP 325 mg/Phenylephrine HCl 5 mg tablets supplied in bulk containers. The affected product is identified by NDC 62959-135-00, with product code C135LA and bulk lot 19F077. Approximately 451,123 tablets are included in this recall.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. This is a voluntary recall initiated by the firm and was classified by the FDA as Class II on February 9, 2022.

The bulk product was distributed to three distributors, who may have further distributed finished products to other entities. Consumers or healthcare professionals who have received products from this recall should contact the recalling firm or their distributor for instructions regarding return or disposal. The recall was terminated on January 7, 2025.

The recalled product

Product
APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
Manufacturer
ULTRAtab Laboratories, Inc.
Category
Drug — Over-the-Counter Combination Tablet
Hazard
  • cgmp-deviation
  • manufacturing-defect

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 (1)

  • Product Codes: C135LA Bulk Lots: 19F077

Distribution

Distribution scope not specified by the agency.

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