The Recall Desk
ModerateFDA (Drugs)·D-0550-2022·Announced 2022-02-16

Pain Aid PMF Caplet Drug Recall for CGMP Deviations

ULTRAtab Laboratories is recalling Pain Aid PMF Caplets due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated the voluntary recall of approximately 1.6 million tablets in bulk form 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 based on CGMP deviations. The source text does not report any illnesses, injuries, or actual product defects causing harm—only manufacturing practice violations. Per the rubric, Class II recalls without reported hospitalization fall to Moderate (score 2).

Plain-English summary

ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling Pain Aid PMF Caplets (Acetaminophen 500 mg, Pamabrom 25 mg) in bulk container form due to Current Good Manufacturing Practice (CGMP) deviations.

The recalled product consists of approximately 1,585,375 tablets with Product Code M710L and Bulk Lot 19A071 (NDC 62959-710-00). The bulk product was distributed to three distributors, who may have distributed finished product to retail customers.

Consumers who have purchased Pain Aid PMF Caplets should stop using the product. Consumers with questions about this recall or their health should contact their healthcare provider or pharmacist.

The recall was initiated by the firm on January 26, 2022, and was classified as a Class II recall by the FDA on February 9, 2022. The recall status is Terminated as of January 7, 2025.

The recalled product

Product
Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00
Manufacturer
ULTRAtab Laboratories, Inc.
Category
Drug — Acetaminophen / Pamabrom Combination
Hazard
  • cgmp-violation
  • manufacturing-deviation

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: M710L Bulk Lots: 19A071

Distribution

Distribution scope not specified by the agency.

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