Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
USPaxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Recalling Firm: Apotex Corp.
Reason for Recall / Hazard
TranslatedFailed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Product Description & Identification
TranslatedPaxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Additional Source Details
| Field | Value |
|---|---|
| City | Weston |
| State | FL |
| Openfda › Upc › 1 | 0360505366835 |
| Openfda › Upc › 2 | 0360505437733 |
| Openfda › Upc › 3 | 0360505366934 |
| Openfda › Unii | X2ELS050D8 |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 1738803 |
| Openfda › Rxcui › 2 | 1738804 |
| Openfda › Rxcui › 3 | 1738805 |
| Openfda › Rxcui › 4 | 1738806 |
| Openfda › Rxcui › 5 | 1738807 |
| Openfda › Rxcui › 6 | 1738808 |
| Openfda › Spl id | 57998b73-87c9-7fed-ffa8-7e43620bd98a |
| Openfda › Brand name | PAXIL |
| Openfda › Spl set id | 483bd97f-c4d0-4e23-aaa8-6334f4471e0c |
| Openfda › Package ndc › 1 | 60505-4377-3 |
| Openfda › Package ndc › 2 | 60505-4378-3 |
| Openfda › Package ndc › 3 | 60505-4379-3 |
| Openfda › Package ndc › 4 | 60505-3668-3 |
| Openfda › Package ndc › 5 | 60505-3669-3 |
| Openfda › Package ndc › 6 | 60505-3670-3 |
| Openfda › Product ndc › 1 | 60505-4377 |
| Openfda › Product ndc › 2 | 60505-4378 |
| Openfda › Product ndc › 3 | 60505-4379 |
| Openfda › Product ndc › 4 | 60505-3668 |
| Openfda › Product ndc › 5 | 60505-3669 |
| Openfda › Product ndc › 6 | 60505-3670 |
| Openfda › Generic name | PAROXETINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | PAROXETINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Apotex Corp |
| Openfda › Application number | NDA020936 |
| Openfda › Is original packager | true |
| Event id | 99673 |
| Address 1 | 2400 N Commerce Pkwy Ste 400 |
| Address 2 | N/A |
| Code info | Lot # TY9494, Exp Date: 05/31/2027. |
| Postal code | 33326-3253 |
| Report date | 20260902 |
| Product type | Drugs |
| Product quantity | 6,972 bottles |
| Reason for recall | Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260813 |
| Initial firm notification | Letter |
| Center classification date | 20260827 |
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 Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toron...?
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 FirmApotex Corp.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.
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🚨 SAFETY ALERT: Apotex Corp. - Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3 Check if your household is affected: https://therecallfile.com/recalls/paxil-cr-paroxetine-extended-release-tablets-37-5mg-30-count-bottle-rx/FDA-D-0804-2026
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