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.
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: 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.
- Hazard
- cgmp-deviation
- manufacturing-process-deviation
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.
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