Acetaminophen 325 mg bulk tablets recalled for manufacturing deviations
ULTRAtab Laboratories is recalling approximately 3.7 million acetaminophen 325 mg tablets due to Good Manufacturing Practice (CGMP) deviations discovered in the manufacturing process.
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 involving manufacturing process deviations with no reported illnesses or injuries documented in the source text. The hazard is manufacturing non-compliance rather than a direct safety defect, and the source does not indicate that finished products reached consumers or caused harm.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling APAP 325 mg (Acetaminophen 325 mg) bulk tablets in response to discovered deviations from Good Manufacturing Practice (CGMP) standards. The recalled product consists of approximately 3,677,483 tablets with product code L200L and bulk lot numbers 18K072 and 19C049.
The bulk product was distributed to three distributors, who may have further distributed finished acetaminophen products to downstream customers. The recall was initiated on January 26, 2022, and classified as a Class II recall by the FDA on February 9, 2022.
Consumers or healthcare providers who have received this product should contact their supplier or ULTRAtab Laboratories for instructions on return or disposal. The recall has been terminated as of January 7, 2025.
The recalled product
- Product
- APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Affected units
- 3,677,483
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 (2)
- Product Codes: L200L Bulk Lots: 18K072
- 19C049
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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