Migrenol Caplet Drug Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 990,197 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: This is an FDA Class II recall for CGMP deviations, a manufacturing/control issue rather than an inherent product hazard. The source text does not report any illnesses, injuries, or hospitalizations. CGMP deviations are precautionary in nature, warranting a Moderate classification rather than High or above.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling Migrenol Caplet bulk containers containing Acetaminophen 500 mg and Caffeine 65 mg. The recall was initiated on January 26, 2022, and was classified as a Class II recall by the FDA.
The product being recalled is identified by NDC 62959-565-00, Product Code M565L, and Bulk Lot 19F014. The recall affects approximately 990,197 tablets distributed in bulk form to three distributors, who may have then distributed finished products to end users.
The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this as a voluntary, firm-initiated recall. No specific distribution information beyond the three initial distributors is provided in this notice.
Consumers who obtained products manufactured under these conditions should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Drug — Analgesic / Pain Reliever
- Affected units
- 990,197
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 (1)
- Product Codes: M565L Bulk Lots: 19F014
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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