Oxycodone and acetaminophen 7.5 mg tablets recalled over a missing imprint
SpecGx is recalling 74,544 bottles of Oxycodone and Acetaminophen CII Tablets, 7.5 mg/325 mg, because of the potential for the imprint to be missing on tablets.
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: Scored 2 under the minor labeling criterion: the record cites a potentially missing tablet imprint with no stated clinical consequence or reported harm.
Plain-English summary
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, from SpecGx LLC of Webster Groves, Missouri, under NDC 0406-0522-01, are being recalled.
The reason given in the enforcement record is a failed tablet specification: there is a potential for the imprint to be missing on tablets.
The recall covers 74,544 bottles from lot 0522J23493, expiring 03/2027. Distribution was nationwide. The FDA has classified the action as Class II.
The imprint is how a tablet is identified. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN)
- Brand
- OXYCODONE AND ACETAMINOPHEN
- Manufacturer
- SpecGx, LLC
- Category
- Drug — Opioid analgesic
- Affected units
- 74,544
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 (2)
- Lot: 0522J23493
- expires: 03/2027.
UPCs (3)
- 0304060522053
- 0304060523050
- 0304060512054
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by SpecGx, 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 2 products in this recall →Related recalls
Same brand · OXYCODONE AND ACETAMINOPHEN
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Same hazard · missing imprint
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- ModerateAkorn Pharma recalls Acetaminophen 500 mg tablets with missing imprints
FDA (Drugs) · 2022-08-24
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