The Recall Desk
ModerateFDA (Drugs)·D-0534-2022·Announced 2022-02-16

Drug Recall: Coated APAP 500 mg Caplets for CGMP Deviations

ULTRAtab Laboratories, Inc. is recalling approximately 2 million Coated APAP 500 mg caplets due to current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors who may have distributed finished product.

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 an FDA Class II drug recall for CGMP deviations with no reported illnesses or injuries. CGMP violations are manufacturing control and process issues rather than direct safety hazards. The source text does not indicate that any illness, injury, or specific hazard has been identified in the product itself.

Plain-English summary

ULTRAtab Laboratories, Inc., located in Highland, New York, is recalling Coated APAP 500 mg caplet (Acetaminophen 500 mg) in bulk containers. The recall involves approximately 2,048,941 tablets with product code L206L and bulk lot 19B002.

The recall was initiated by the manufacturer on January 26, 2022, due to Current Good Manufacturing Practice (CGMP) deviations. CGMP deviations relate to the manufacturing processes and controls used to produce the drug.

The bulk product was distributed to 3 distributors, who may have distributed finished product containing the affected material. Consumers or healthcare providers who have this product should contact the recalling firm or their distributor for instructions on return or disposal.

The FDA classified this recall as Class II on February 9, 2022. The recall was terminated on January 7, 2025.

The recalled product

Product
Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00
Manufacturer
ULTRAtab Laboratories, Inc.
Category
Drug — Acetaminophen / Over-the-Counter Pain Reliever
Hazard
  • cgmp-deviation
  • manufacturing-control

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: L206L Bulk Lots: 19B002

Distribution

Distribution scope not specified by the agency.

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