Drug Recall: Normed APAP 325 mg Acetaminophen Bulk Tablets
ULTRAtab Laboratories is voluntarily recalling Normed APAP 325 mg acetaminophen bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 3.7 million tablets distributed 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: This is an FDA Class II recall involving CGMP deviations with no reported illnesses or injuries. The source text does not indicate any hospitalization reports or actual harm, making this a precautionary manufacturing-compliance recall that falls under the Moderate category.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling Normed APAP 325 mg (Acetaminophen 325 mg) bulk containers. The recall affects product with NDC 62959-203-00, product codes L203L, and bulk lot numbers 18K012 and 19E091, totaling approximately 3,667,885 tablets.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The bulk product was distributed to three distributors, who may have further distributed finished pharmaceutical products made from this bulk material.
Consumers and healthcare professionals who may have products manufactured from this bulk recall lot should consult their healthcare provider or pharmacist. The FDA classified this as a Class II recall, and the recall was voluntarily initiated by the firm on January 26, 2022. The recall was terminated on January 7, 2025.
The recalled product
- Product
- Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Affected units
- 3,667,885
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: L203L Bulk Lots: 18K012
- 19E091
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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