The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0537-2022·Announced 2022-02-16

APAP 500 mg Acetaminophen Recalled Due to CGMP Deviations

ULTRAtab Laboratories is recalling APAP 500 mg SRC Coated tablets in bulk due to manufacturing process deviations. The company voluntarily initiated the Class II recall on January 26, 2022.

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 without reported illnesses or injuries. The source text contains no evidence of harm or contamination—only manufacturing process compliance issues—placing this recall at the Moderate level per the rubric.

Plain-English summary

ULTRAtab Laboratories, Inc., of Highland, New York, is recalling APAP 500 mg SRC Coated (Acetaminophen 500 mg) tablets distributed in bulk containers. The recall affects approximately 18.8 million tablets with product code L211L and bulk lot numbers 18M043, 18M044, 18M045, 19B032, 19B033, 19B034, 19F008, 19F009, and 19F010 (NDC 62959-211-00).

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturer's processes. The bulk product was distributed to 3 distributors, who may have further distributed finished product containing these tablets.

This is a voluntary Class II recall initiated by the firm on January 26, 2022, and terminated on January 7, 2025. The FDA notified the firm by letter on February 9, 2022. Consumers or healthcare providers who have this product should contact their distributor or the manufacturer for return instructions.

The recalled product

Product
APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00
Manufacturer
ULTRAtab Laboratories, Inc.
Category
Drug — Acetaminophen
Hazard
Affected units
18,772,640

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 (9)

  • Product Codes: L211L Bulk Lots: 18M043
  • 18M044
  • 18M045
  • 19B032
  • 19B033
  • 19B034
  • 19F008
  • 19F009
  • 19F010

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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