The Recall Desk
ModerateFDA (Drugs)·D-911-2014·Announced 2014-01-29

Saccharomyces Boulardii Capsules Recalled for Potential Label Mixup

Aidapak Services is recalling Saccharomyces Boulardii capsules because they may have been mislabeled as other prescription drugs.

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 recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error (mislabeling) without reported injuries, fitting the 'Moderate' criteria for minor labeling errors or low-risk contamination.

Plain-English summary

Aidapak Services, LLC is recalling 2,024 capsules of Saccharomyces Boulardii Lyo, 250 mg, NDC 00414200007. The recall was initiated because the product may have been mislabeled as one of several other prescription drugs, including Pregabalin, Hyoscyamine Sulfate, or Varenicline.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text does not specify the number of affected units or report any illnesses or injuries associated with this labeling error.

Consumers should check their medication for the specific NDC and pedigree codes listed in the recall notice. If the product matches the recalled items, they should contact their pharmacist or healthcare provider for instructions on how to return the medication or obtain a replacement.

The recalled product

Product
SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00414200007.
Affected units
2,024

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 (16)

  • SACCHAROMYCES BOULARDII LYO
  • Capsule
  • 250 mg has the following codes: Pedigree: AD21859_1
  • EXP: 10/31/2013
  • Pedigree: AD54586_1
  • EXP: 5/21/2014
  • Pedigree: W003030
  • EXP: 6/12/2014
  • Pedigree: W003866
  • EXP: 6/27/2014
  • Pedigree: AD37063_7
  • EXP: 5/13/2014
  • Pedigree: W002917
  • EXP: 6/10/2014
  • Pedigree: AD54586_4
  • EXP: 5/21/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 265 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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