The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-863-2014·Announced 2014-01-29

Aidapak Recalls CapsuleTOPRIL Tablets Due to Potential Labeling Error

Aidapak Services, LLC is recalling CapsuleTOPRIL tablets because they may have been mislabeled as Calcitriol capsules. The error could lead to patients receiving the wrong medication.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 CapsuleTOPRIL, Tablet, 12.5 mg (NDC 00143117101) due to a potential labeling error. The recalled product may have been mislabeled as CALCITRIOL, Capsule, 0.25 mcg (NDC 00054000725). The affected product has the pedigree AD52778_16 and an expiration date of 5/20/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as FDA Class II, indicating a situation that might temporarily cause or contribute to reversible adverse health consequences.

Healthcare providers and patients should check their inventory and prescriptions for CapsuleTOPRIL tablets with the specified pedigree and expiration date. If the product is found, it should be returned to the distributor or pharmacy for replacement or refund. Patients should consult their healthcare provider if they have questions about their medication.

The recalled product

Product
CapsuleTOPRIL, Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00143117101.
Affected units
100

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 (4)

  • CapsuleTOPRIL
  • Tablet
  • 12.5 mg has the following codes: Pedigree: AD52778_16
  • EXP: 5/20/2014.

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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