FDA Recall D-0255-2026

SpecGx, LLC · Webster Groves, MO

Class II Ongoing 149 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493

Lot / code: Lot: 0522J23493, expires: 03/2027.

Quantity: 74,544 bottles

Reason for recall

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Recall record

Recall number: D-0255-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide
Recall initiated: 2025-12-16
Classified by FDA Center: 2026-01-07
FDA published: 2026-01-14
Recalling firm: SpecGx, LLC
Firm location: Webster Groves, MO

Drug identification

Brand name(s): OXYCODONE AND ACETAMINOPHEN
Generic name(s): OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
Manufacturer(s): SpecGx LLC
NDC(s): 0406-0512, 0406-0522, 0406-0523
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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