Extra-Strength Unaspirin Caplet Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Extra-Strength Unaspirin caplets (Acetaminophen 500 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 6.2 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: The recall is classified as FDA Class II and is voluntary with no reported illnesses or injuries. CGMP deviations are manufacturing process concerns that may affect product quality or safety but do not represent an immediate hazard of serious injury or death. This meets the rubric criterion for Moderate severity.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, NY, is recalling Extra-Strength Unaspirin caplets (Acetaminophen 500 mg) sold in bulk containers. The affected product is identified by NDC 62959-207-00, Product Code L207L, and Bulk Lots 18K111, 19E104, and 19F050. Approximately 6,215,512 tablets are subject to this recall.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. Bulk product was distributed to three distributors, who may have distributed finished products to downstream customers.
This is a voluntary recall initiated by the firm. The recall was classified as FDA Class II on February 9, 2022, and the firm notification process began on January 26, 2022. The recall was terminated on January 7, 2025.
Consumers or healthcare providers who have this product should discontinue use and contact their supplier or distributor for instructions on return or disposal.
The recalled product
- Product
- Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Affected units
- 6,215,512
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 (3)
- Product Codes: L207L Bulk Lots: 18K111
- 19E104
- 19F050
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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