Acetaminophen 325 mg Pamabrom Tablets Recalled Due to Manufacturing Violations
ULTRAtab Laboratories voluntarily recalled approximately 6.4 million APAP 325 mg tablets due to current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors who may have distributed finished products.
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: FDA classified this as Class II, but the source specifies only CGMP deviations with no reported illnesses or injuries. This represents a precautionary manufacturing-quality recall rather than an active hazard with injury reports, fitting the Moderate criteria for low-risk quality/compliance issues.
Plain-English summary
ULTRAtab Laboratories, Inc. of Highland, New York is voluntarily recalling APAP 325 mg tablets containing Acetaminophen 325 mg and Pamabrom 25 mg in bulk container form. The recall covers approximately 6,380,282 tablets with product code M700LA and bulk lot numbers 18K037, 18L093, 18M006, 19A121, 19G044, 19G045, and 19G046.
The firm initiated this recall on January 26, 2022, citing current Good Manufacturing Practice (CGMP) deviations as the reason. The FDA classified this as a Class II recall. The affected bulk product was distributed to three distributors, who may have distributed finished products containing the recalled tablets.
Consumers or healthcare providers who have this product should stop using it and contact their supplier for instructions on return or disposal. No adverse events or illnesses have been reported in the source material provided. The recall was terminated as of January 7, 2025.
The recalled product
- Product
- APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Hazard
- cgmp-deviation
- manufacturing-quality
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 (7)
- Product Codes: M700LA Bulk Lots: 18K037
- 18L093
- 18M006
- 19A121
- 19G044
- 19G045
- 19G046
Distribution
Distribution scope not specified by the agency.
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