The Recall Desk
ModerateFDA (Drugs)·D-490-2014·Announced 2014-01-22

FDA Recalls Ferrous Sulfate Tablets Due to Potential Label Mixup

Aidapak Services is recalling ferrous sulfate tablets that may be mislabeled as ramipril capsules. The error involves a label mixup on repacked 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 and involves a labeling error (label mixup) without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling specific lots of Ferrous Sulfate, Tablet, 325 mg (65 mg Elemental Iron), Over The Counter. The recall is due to a labeling error where the product may be mislabeled as Ramipril, Capsule, 2.5 mg. The affected product has the pedigree AD54553_1 and an expiration date of 5/20/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The mislabeling involves a mixup with Ramipril, Capsule, 2.5 mg, NDC 68180058901, Pedigree AD54549_16, which also has an expiration date of 5/20/2014.

Consumers should check their medication for the specific pedigree and expiration date listed above. If the product matches the recalled description, they should stop using it and contact their pharmacist or healthcare provider for guidance.

The recalled product

Product
FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904759160
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)

  • FERROUS SULFATE
  • Tablet
  • 325 mg (65 mg Elemental Iron) has the following code Pedigree: AD54553_1
  • EXP: 5/20/2014.

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

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