Acetaminophen 500 mg tablets recalled for CGMP deviations
ULTRAtab Laboratories is recalling approximately 6.2 million acetaminophen 500 mg tablets due to current good manufacturing practice (CGMP) deviations. The recall is voluntary and was initiated by the manufacturer.
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 represent a manufacturing quality issue rather than an acute safety hazard, warranting a Moderate severity rating.
Plain-English summary
ULTRAtab Laboratories, Inc. is recalling APAP 500 mg tablets (acetaminophen 500 mg) in bulk containers distributed under NDC 62959-210-00. The recall affects approximately 6,249,082 tablets.
The manufacturer initiated this voluntary recall due to deviations from current good manufacturing practice (CGMP) standards. The bulk product was distributed to 3 distributors, who may have further distributed finished product to downstream customers.
Affected product lots are 18L120, 19B044, and 19E082, with product code L210L. The recall was initiated on January 26, 2022, and classified as Class II by the FDA on February 9, 2022.
Customers who have received this product should contact their supplier or the manufacturer for instructions on product disposition and replacement.
The recalled product
- Product
- APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Affected units
- 6,249,082
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: L210L Bulk Lots: 18L120
- 19B044
- 19E082
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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