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
USOxycodone 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
Recalling Firm: SpecGx, LLC
Reason for Recall / Hazard
TranslatedFailed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Product Description & Identification
TranslatedOxycodone 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
Affected Products
TranslatedOxycodone 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
Additional Source Details
| Field | Value |
|---|---|
| City | Webster Groves |
| State | MO |
| Openfda › Upc › 1 | 0304060522053 |
| Openfda › Upc › 2 | 0304060523050 |
| Openfda › Upc › 3 | 0304060512054 |
| Openfda › Unii › 1 | 362O9ITL9D |
| Openfda › Unii › 2 | C1ENJ2TE6C |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 1049214 |
| Openfda › Rxcui › 2 | 1049221 |
| Openfda › Rxcui › 3 | 1049225 |
| Openfda › Spl id | 38cc2423-8e75-4007-b224-75aa920582d7 |
| Openfda › Brand name | OXYCODONE AND ACETAMINOPHEN |
| Openfda › Spl set id | f2137f1a-b49a-40bd-97ac-cd6b36e295f4 |
| Openfda › Package ndc › 1 | 0406-0512-01 |
| Openfda › Package ndc › 2 | 0406-0512-05 |
| Openfda › Package ndc › 3 | 0406-0512-62 |
| Openfda › Package ndc › 4 | 0406-0512-23 |
| Openfda › Package ndc › 5 | 0406-0512-91 |
| Openfda › Package ndc › 6 | 0406-0522-01 |
| Openfda › Package ndc › 7 | 0406-0522-62 |
| Openfda › Package ndc › 8 | 0406-0522-05 |
| Openfda › Package ndc › 9 | 0406-0522-23 |
| Openfda › Package ndc › 10 | 0406-0523-01 |
| Openfda › Package ndc › 11 | 0406-0523-62 |
| Openfda › Package ndc › 12 | 0406-0523-05 |
| Openfda › Package ndc › 13 | 0406-0523-23 |
| Openfda › Package ndc › 14 | 0406052201 |
| Openfda › Product ndc › 1 | 0406-0512 |
| Openfda › Product ndc › 2 | 0406-0522 |
| Openfda › Product ndc › 3 | 0406-0523 |
| Openfda › Generic name | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name › 1 | ACETAMINOPHEN |
| Openfda › Substance name › 2 | OXYCODONE HYDROCHLORIDE |
| Openfda › Manufacturer name | SpecGx LLC |
| Openfda › Application number | ANDA087463 |
| Openfda › Is original packager | true |
| Event id | 98136 |
| Address 1 | 385 Marshall Ave |
| Code info | Lot: 0522J23493, expires: 03/2027. |
| Postal code | 63119-1831 |
| Report date | 20260114 |
| Product type | Drugs |
| Product quantity | 74,544 bottles |
| Reason for recall | Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251216 |
| Initial firm notification | |
| Center classification date | 20260107 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 6311...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Overview
- Recalling FirmSpecGx, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide
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🚨 SAFETY ALERT: SpecGx, LLC - 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 Check if your household is affected: https://therecallfile.com/recalls/oxycodone-and-acetaminophen-cii-tablets-usp-7-5-mg-325-mg-100-tablets/FDA-D-0255-2026
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