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.
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 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.
- Affected units
- 2,048,941
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.
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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