FDA Recalls Propafenone HCL Tablets Due to Potential Labeling Mixup
Aidapak Services, LLC is recalling Propafenone HCL 150 mg tablets because they may have been mislabeled as Fosinopril Sodium 10 mg tablets.
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 situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling mixup, which fits the criteria for moderate severity.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Propafenone HCL, Tablet, 150 mg, distributed by Aidapak Services, LLC. The recall is due to a labeling mixup where the Propafenone HCL tablets may have been mislabeled as Fosinopril Sodium, Tablet, 10 mg.
The affected product is identified by NDC 00591058201, with a pedigree of AD54549_13 and an expiration date of 5/20/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The potential mislabeling involves Fosinopril Sodium, Tablet, 10 mg, NDC 00185004109, Pedigree: AD54549_7, EXP: 5/20/2014.
Consumers and healthcare providers should check their inventory for the specific Propafenone HCL tablets listed above. If the product is found, it should be returned to the distributor or pharmacy for proper handling. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- PROPAFENONE HCL, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591058201.
- 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)
- PROPAFENONE HCL
- Tablet
- 150 mg has the following codes: Pedigree: AD54549_13
- EXP: 5/20/2014.
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.
See all 265 products in this recall →Related recalls
Same manufacturer · Aidapak Services, LLC
See all →- ModerateAidapak Recalls Sennosides Tablets Due to Potential Labeling Errors
FDA (Drugs) · 2014-01-29
- ModerateLevothyroxine Sodium Tablets Recalled for Potential Labeling Mixup
FDA (Drugs) · 2014-01-29
- ModerateAidapak Recalls Mislabeled Pantoprazole Sodium DR Tablets
FDA (Drugs) · 2014-01-29
- ModerateAidapak Recalls Nifedipine ER Tablets Due to Potential Label Mixup
FDA (Drugs) · 2014-01-29
- ModerateSimvastatin Tablets Recalled for Potential Labeling Error
FDA (Drugs) · 2014-01-29
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02