FDA Recalls Hydrocodone/Acetaminophen Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Hydrocodone Bitartrate/Acetaminophen tablets because they may be mislabeled as Melatonin. The recall covers repacked drugs distributed in four western states.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe. While no injuries are explicitly reported in the text, the potential for a patient to take a potent opioid instead of a supplement (or vice versa) represents a significant risk of harm, aligning with the Severe criteria for Class II recalls with potential for serious adverse events.
Plain-English summary
Aidapak Services, LLC is recalling Hydrocodone Bitartrate/Acetaminophen Tablets, 7.5 mg/325 mg, NDC 52544016201. The recall is due to a labeling error where the product may be mislabeled as Melatonin, Tablet, 3 mg, NDC 51991001406. The affected product has the pedigree W004005 and an expiration date of 7/1/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text does not specify the exact number of units recalled or the specific facilities receiving the product.
Consumers and healthcare providers should check their inventory for this specific NDC and pedigree. If found, the product should be removed from use and returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider for alternative pain management options if they have been prescribed this medication.
The recalled product
- Product
- HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52544016201
- 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)
- HYDROcodone BITARTRATE/ ACETAMINOPHEN
- Tablet
- 7.5 mg/325 mg has the following code Pedigree: W004005
- EXP: 7/1/2014.
Distribution
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.
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