The Recall Desk
ModerateFDA (Drugs)·D-570-2014·Announced 2014-01-22

Loratadine Tablets Recalled for Potential Labeling Mixup

Aidapak Services is recalling Loratadine 10 mg tablets because they may be mislabeled as Glycopyrrolate or Omega-3 fatty acids.

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 and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling Loratadine Tablet, 10 mg, Rx only, NDC 45802065078. The recall is due to a labeling mixup where the product may be mislabeled as Glycopyrrolate Tablet, 2 mg, or Omega-3 Fatty Acid Capsule, 1000 mg.

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves 799 tablets with specific pedigree and expiration codes listed in the agency notice.

Consumers should check their medication for the NDC 45802065078 and contact their pharmacist or healthcare provider for instructions on how to proceed.

The recalled product

Product
LORATADINE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802065078
Affected units
799

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 (8)

  • LORATADINE
  • Tablet
  • 10 mg has the following codes Pedigree: W002652
  • EXP: 6/5/2014
  • Pedigree: AD22865_7
  • EXP: 5/2/2014
  • Pedigree: W003253
  • EXP: 6/17/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 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 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

See all →