FDA Recalls Isoniazid Tablets Due to Potential Labeling Errors
Aidapak Services, LLC is recalling Isoniazid 300 mg 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 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) without reported injuries or illnesses, which aligns with the rubric for moderate severity involving minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Aidapak Services, LLC is voluntarily recalling Isoniazid, Tablet, 300 mg, NDC 00555007102, in 600-tablet packages. The recall was initiated because the medication may have been mislabeled as other prescription drugs, including hydroxyzine pamoate, cetirizine HCl, ranolazine ER, or duloxetine HCl DR.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The affected lots have pedigree codes W003691, AD32757_31, AD32757_28, and AD60272_70, with expiration dates ranging from May 13, 2014, to June 26, 2014.
Consumers should check their medication packaging for the NDC 00555007102 and the specific pedigree codes listed above. If the medication matches these details, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on appropriate disposal or replacement.
The recalled product
- Product
- ISONIAZID, Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555007102.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 600
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)
- ISONIAZID
- Tablet
- 300 mg has the following codes: Pedigree: W003691
- EXP: 6/26/2014
- Pedigree: AD32757_31
- EXP: 5/13/2014
- Pedigree: AD32757_28
- Pedigree: AD60272_70
- EXP: 5/22/2014.
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
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
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
- SevereMirtazapine Tablets Recalled for Potential Mislabeling as Isoniazid
FDA (Drugs) · 2014-01-22
- SevereAidapak Recalls Trazodone Tablets Due to Potential Label Mixup
FDA (Drugs) · 2014-01-22
- ModerateFDA Recalls Tizanidine Tablets Due to Potential Labeling Mixup
FDA (Drugs) · 2014-01-22
- SevereAidapak Recalls Olanzapine Tablets Due to Potential Labeling Errors
FDA (Drugs) · 2014-01-22
- SevereFDA Recalls Tizanidine Tablets Due to Potential Labeling Error
FDA (Drugs) · 2014-01-22
- ModerateAidapak Recalls OXcarbazepine Tablets Due to Potential Labeling Error
FDA (Drugs) · 2014-01-22