Oxycodone blister cards recalled over seals that let tablets fall out
Amerisource Health Services is recalling 31,676 packages of Oxycodone Hydrochloride Tablets 5 mg over card seal defects that let tablets fall out of their cavities.
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: Scored 3 under the risk-of-harm criterion: the firm states the seals let tablets fall out of their cavities, leaving a controlled opioid unsecured, and no injuries are reported.
Plain-English summary
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, in 100-count (10 x 10) blister cards per carton, Rx only, containing product from NDC 10702-018 by KVK-Tech Inc., are being recalled by Amerisource Health Services LLC.
The reason given in the enforcement record is a defective container: card seal defects, described as weak or non-existent seals, leading to the tablets falling out of their cavities.
The record lists 31,676 packages from lots 1027932 (expiry 06/30/2027) and 1028360 (expiry 08/31/2027). Distribution was nationwide in the USA. The FDA has classified the action as Class II.
A blister card that does not retain its tablets leaves a controlled opioid loose in the carton. The record reports no injuries. Patients and pharmacies should follow the firm's instructions and keep the product secured.
The recalled product
- Product
- OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
- Brand
- OXYCODONE HYDROCHLORIDE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Opioid analgesic
- Affected units
- 31,676
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)
- Lots #: 1027932
- Exp Date 06/30/2027
- 1028360
- Exp Date 08/31/2027
Distribution
Distributed nationwide across the United States.
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