The Recall Desk
HighFDA (Drugs)·D-0276-2026·Announced 2026-01-21

Pepcid Complete recalled due to rodent exposure in distribution facility

Gold Star Distribution is recalling Pepcid Complete 25CT tablets nationwide due to CGMP deviations, including insanitary conditions and rodent activity discovered in their distribution center.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for CGMP violations involving rodent contamination at a pharmaceutical distribution center. While no illnesses have been reported, rodent exposure presents a genuine risk of product contamination with pathogens or foreign material, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Gold Star Distribution Inc is recalling Pepcid Complete 25CT tablets distributed nationwide. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified at the company's distribution center.

The FDA investigation found insanitary conditions and evidence of rodent exposure and activity at the distribution facility. All lots of Pepcid Complete 25CT within expiration date that were distributed by Gold Star Distribution are included in this recall.

The recalled product

Product
PEPCID COMPLETE - 25CT
Manufacturer
GOLD STAR DISTRIBUTION INC
Category
Drug
Hazard
  • rodent-contamination
  • insanitary-conditions

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)

  • All lots within expiry distributed by Gold Star Distribution.

Distribution

Distributed nationwide across the United States.

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