FDAdrugHigh PriorityActive

Baclofen Contamination Recall

Baclofen Tablets 10 mg has been recalled due to possible contamination with foreign particles. Consumers who purchased this product should stop using it immediately. Check the official FDA notice for specific lot numbers and return or disposal instructions.

By RecallRadar Editorial Team

Sourced from FDA. Last verified March 4, 2026.

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Key facts

Date announced
November 26, 2025
Source agency
FDA

This recall involves safety concerns. Take action promptly.

Plain-English Summary

Baclofen Tablets 10 mg has been recalled due to possible contamination with foreign particles. Consumers who purchased this product should stop using it immediately. Check the official FDA notice for specific lot numbers and return or disposal instructions.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

Presence of Foreign Tablets/Capsules

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand
Fda
Category
drug
Source agency
FDA
Announced
November 26, 2025
Country
US
Status
Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Lot GS065762

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

  1. 1## Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10 Agency: FDA | Category: drug Reason: Presence of Foreign Tablets/Capsules What to do:
  2. 2Stop using the product if your lot/model matches.
  3. 3Check the FDA notice for specifics.
  4. 4Follow remedy instructions.
Open Official Recall NoticeGet Alerts for FDA Devices

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
FDA
Announced by source
November 26, 2025
Last reviewed by RecallRadar
March 4, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists Lot GS065762.

What is the remedy for this recall?

## Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10 Agency: FDA | Category: drug Reason: Presence of Foreign Tablets/Capsules What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: FDA recall hub and Food & Drug recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from FDA

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