The Recall Desk
ModerateFDA (Drugs)·D-0547-2022·Announced 2022-02-16

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.

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: 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
Hazard
  • cgmp-deviations
  • manufacturing-control-issue

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.

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