The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0538-2022·Announced 2022-02-16

HPC Tablet Drug Recalled Due to CGMP Manufacturing Deviations

ULTRAtab Laboratories is recalling HPC Tablet (a combination of acetaminophen, aspirin, caffeine, and salicylamide) due to manufacturing deviations. The recall affects approximately 50 million tablets distributed in bulk 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: The FDA classified this as a Class II recall, but the source text explicitly states no illnesses or injuries have been reported. The hazard is manufacturing-process deviation without documented harm. This falls under the voluntary, precautionary category matching the Moderate severity level.

Plain-English summary

ULTRAtab Laboratories, Inc., a pharmaceutical manufacturer located in Highland, New York, is voluntarily recalling HPC Tablet in bulk container form. The product contains acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4 mg, and salicylamide 152 mg per tablet. Approximately 50,585,623 tablets are affected by this recall.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during the company's manufacturing process. The FDA classified this as a Class II recall, and the recalling firm initiated the action voluntarily through written notification.

The bulk product was distributed to three distributors, who may have further distributed finished products. Affected lot codes include multiple batches across product codes L242SRC, L242L, L242PA, and L242N, with lot numbers ranging from 18F072 through 19H040. Consumers who have this product should contact their healthcare provider if they have any questions or concerns about the recall.

The recalled product

Product
HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
Manufacturer
ULTRAtab Laboratories, Inc.
Category
Drug — Over-the-Counter Combination Analgesic
Hazard
Affected units
50,585,623

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 (17)

  • Product Codes: L242SRC Bulk Lot: 18K086
  • 18L009
  • 18L050
  • 18L083
  • 18M025
  • 18M073
  • 18M098
  • 19A010
  • 19A084
  • 19A105
  • 19A107
  • Product Code: L242L Bulk Lot: 19H014
  • Product Code: L242PA Bulk Lot: 18F072
  • 18L119
  • 19A067
  • 19G043
  • Product Code: L242N Bulk Lot: 19H040

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.

See all 33 products in this recall →

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