The Recall Desk
ModerateFDA (Drugs)·D-0524-2022·Announced 2022-02-16

Cold Tabs Drug Recalled for CGMP Manufacturing Deviations

ULTRAtab Laboratories is recalling 4-Component Cold Tabs in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The affected product was 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: The FDA classified this as a Class II recall, and the source text does not report any illnesses, injuries, or adverse events. The hazard is a manufacturing process deviation rather than a specific safety defect with demonstrated harm. This is a precautionary recall based on process deviations.

Plain-English summary

ULTRAtab Laboratories, Inc. is recalling 4-Component Cold Tabs (containing Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15 mg, and Phenylephrine HCl 5 mg) in bulk container form. A total of 19,103,287 tablets are affected.

The recall is being issued due to Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process. The bulk product was distributed to three distributors, who may have distributed the finished product further.

Affected lots are identified by product codes C107L (bulk lots 18G085, 19B061, 19F066, 19J068), C107LB (bulk lots 18J051, 18M079, 18M080, 19B017, 19B018, 19C001, 19C081, 19D056, 19D057), and C107LA (bulk lot 19F067). The firm initiated this recall voluntarily on January 26, 2022, and the recall was terminated on January 7, 2025.

Consumers should contact their healthcare provider or pharmacist if they have questions about this product.

The recalled product

Product
4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00
Manufacturer
ULTRAtab Laboratories, Inc.
Category
Drug — Over-the-Counter Cold/Cough Medication
Hazard
  • cgmp-deviation
  • manufacturing-defect

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 (12)

  • Product Code: C107L Bulk Lots: 18G085
  • 19B061
  • 19F066
  • 19J068 Product Code: C107LB Bulk Lots: 18J051
  • 18M079
  • 18M080
  • 19B017
  • 19B018
  • 19C001
  • 19C081
  • 19D056
  • 19D057 Product C107LA: Bulk lots: 19F067

Distribution

Distribution scope not specified by the agency.

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