The Recall Desk
HighFDA (Devices)·Z-1024-2026·Announced 2026-01-21

Pepto Bismol recalled over insanitary conditions at a distribution center

Gold Star Distribution is recalling Pepto Bismol over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its 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: Scored 3 under the risk-of-harm criterion: the record cites insanitary conditions with rodent activity affecting distributed product, and no illnesses are reported.

Plain-English summary

Pepto Bismol, 32 count, distributed by Gold Star Distribution Inc, is being recalled.

The reason given in the enforcement record is CGMP deviations: insanitary conditions including rodent exposure and activity in the firm's distribution center.

The recall covers all lots within expiry distributed by Gold Star Distribution. The record does not state a quantity. Distribution was nationwide in the US. The FDA has classified the action as Class II.

Consumers who have this product should not use it and should follow the retailer's return instructions.

The recalled product

Product
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Manufacturer
REPLIGEN CORPORATION
Category
Drug — Antidiarrheal
Hazard
  • insanitary-conditions
  • rodent-activity
  • cgmp-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)

  • PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category