Aidapak Recalls Mycophenolate Mofetil Tablets Due to Labeling Error
Aidapak Services, LLC is recalling 500 mg Mycophenolate Mofetil tablets because they may be mislabeled as 250 mg capsules.
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 (label mixup) with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling 100-tablet bottles of Mycophenolate Mofetil, 500 mg tablets (NDC 00004026001) due to a labeling error. The recalled tablets may be mislabeled as Mycophenolate Mofetil, 250 mg capsules (NDC 00004025901). The affected product has the pedigree AD49414_4 and an expiration date of 5/17/2014.
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 serious adverse health consequences or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- MYCOPHENOLATE MOFETIL, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00004026001.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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)
- MYCOPHENOLATE MOFETIL
- Tablet
- 500 mg has the following codes: Pedigree: AD49414_4
- EXP: 5/17/2014.
Distribution
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.
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