Legatrin Acetaminophen and Diphenhydramine Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Legatrin bulk tablets due to manufacturing deviations that may affect product quality and safety. The company voluntarily initiated the recall after distributing approximately 14 million tablets 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 recall is classified as FDA Class II and involves CGMP manufacturing deviations. However, no specific illnesses, injuries, or product failures are reported in the source text, and the recall is precautionary in nature based on process deviations rather than confirmed harm.
Plain-English summary
ULTRAtab Laboratories, Inc. is recalling Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container tablets due to deviations from Current Good Manufacturing Practices (CGMP). The product was distributed in bulk form to three distributors, who may have further distributed finished products containing these ingredients.
The recalled bulk lots include product codes M785L with lot numbers 18K029, 18L059, 18M100, 19B013, 19D024, 19D059, 19E029, and 19J050. Approximately 14,066,434 tablets were affected by this recall.
This is a voluntary recall initiated by ULTRAtab Laboratories. The FDA classified this recall as Class II. Consumers or healthcare providers who have received products containing this bulk material should contact their supplier or ULTRAtab Laboratories with questions about whether they have received affected product.
The recalled product
- Product
- Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Affected units
- 14,066,434
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 (8)
- Product Codes: M785L Bulk Lots: 18K029
- 18L059
- 18M100
- 19B013
- 19D024
- 19D059
- 19E029
- 19J050
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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