Aidapak Recalls Guanfacine Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling guanfacine HCl tablets because they may have been mislabeled as other prescription drugs.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a label mixup that could result in patients receiving incorrect prescription medications, posing a risk of harm.
Plain-English summary
Aidapak Services, LLC is recalling guanfacine HCl tablets, 1 mg, NDC 00591044401, due to a potential labeling error. The recall involves 500-tablet units that were repacked and distributed in Arizona, California, Oregon, and Washington.
The FDA has identified a label mixup where the guanfacine tablets may have been mislabeled as other medications, including bupropion HCl ER, omega-3 fatty acid, or omeprazole/sodium bicarbonate. This error could lead to patients receiving the wrong medication.
Patients and healthcare providers should check their inventory for the specific pedigree codes and expiration dates listed in the recall notice. If the product is found, it should be returned to the distributor or the FDA should be contacted for further instructions.
The recalled product
- Product
- guanFACINE HCl, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591044401.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 500
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 (9)
- guanFACINE HCl
- Tablet
- 1 mg has the following codes: Pedigree: W002728
- EXP: 4/30/2014
- Pedigree: AD39611_1
- Pedigree: W003791
- EXP: 6/27/2014
- Pedigree: AD73525_13
- EXP: 4/30/2014.
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 →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- SevereAidapak Recalls Guanfacine Tablets Due to Potential Label Mixup
FDA (Drugs) · 2014-01-22
- ModerateAidapak Recalls Hydroxychloroquine Tablets Due to Potential Label Mixup
FDA (Drugs) · 2014-01-22
- ModerateFDA Recalls Cinacalcet HCL Tablets Due to Potential Labeling Mixup
FDA (Drugs) · 2014-01-22
- ModerateAidapak Recalls Trazodone Tablets Due to Potential Labeling Errors
FDA (Drugs) · 2014-01-22
- SevereAidapak Recalls Clomipramine Capsules Due to Potential Labeling Errors
FDA (Drugs) · 2014-01-22
- ModerateAidapak Recalls Irbesartan Tablets Due to Potential Labeling Mixup
FDA (Drugs) · 2014-01-22