Baclofen recalls
The FDA has published 16 recalls involving Baclofen since 2012. The latest was reported on 24 Dec 2025. Most were for sterility. Franck's Lab Inc., d.b.a. Franck's Compounding Lab has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 16 since 2012
Last 12 months 1 reported
Class I 0 0% of total
Ongoing 1 latest 24 Dec 2025
Recalls per month, last 24 months click a bar for that month Severity split
0 0%16 100%0 0%
Ongoing baclofen recalls 1 active
All baclofen recalls, newest first 16 total Reported Class Recall Company Reason Where 24 Dec 2025 Drug CLASS II Baclofen Tablets USP, 10 mg recalled by Golden State Medical Supply Baclofen Golden State Medical Supply Other Nationwide 22 Jan 2020 Drug CLASS II Baclofen 2000MCG/ML INJ in syringe Assurance Infusion (713) recalled Assurance Infusion Sterility Nationwide 18 Dec 2019 Drug CLASS II Baclofen and Clonidine HCL and Morphine Sulfate recalled Coast Quality Pharmacy Packaging Defects Nationwide 7 Aug 2019 Drug CLASS II Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe recalled Gablofen Piramal Critical Care Potency & Assay Nationwide 16 Mar 2016 Drug CLASS II Baclofen 5000 mcg/ml, vol recalled by Hartley Medical Center Hartley Medical Center Pharmacy Sterility Nationwide 16 Mar 2016 Drug CLASS II Baclofen 2000 mcg/ml, vol recalled by Hartley Medical Center Hartley Medical Center Pharmacy Sterility Nationwide 9 Mar 2016 Drug CLASS II Baclofen, 2.5 mg/mL INJ, in vial recalled by TexasStar Pharmacy TexasStar Pharmacy Sterility TX 27 Jan 2016 Drug CLASS II Baclofen 1 mg/ml in NS syringe, For Intrathecal Use Only recalled Amerita Specialty Infusion Services Sterility AZ 27 Jan 2016 Drug CLASS II Baclofen USP powder recalled by Freedom Pharmaceuticals Freedom Pharmaceuticals Packaging Defects Nationwide 20 May 2015 Drug CLASS II Baclofen 20 mg/ Susp., Health Innov Pharmacy recalled Health Innovations Pharmacy Sterility NC 12 Jun 2013 Drug CLASS II Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable vial recalled The Compounding Shop Sterility 4 states 12 Jun 2013 Drug CLASS II Baclofen 500 mcg/mL Injectable vial recalled by The Compounding Shop The Compounding Shop Sterility 4 states 22 Aug 2012 Drug CLASS II Baclofen/bupivacaine/clonidine/morphine recalled Franck's Lab Inc., d.b.a. Franck's Compounding Lab Sterility Nationwide 22 Aug 2012 Drug CLASS II Baclofen, P.f. (with 0.9% P.f. Normal Saline) 2,000mcg/ML recalled Franck's Lab Inc., d.b.a. Franck's Compounding Lab Sterility Nationwide 22 Aug 2012 Drug CLASS II Baclofen/hydromorphone, P.f. 2000mcg/2.9mg/ML Intrathecal recalled Franck's Lab Inc., d.b.a. Franck's Compounding Lab Sterility Nationwide 22 Aug 2012 Drug CLASS II Baclofen/morphine, P.f. 1,000mcg/25mg/ML Intrathecal recalled Franck's Lab Inc., d.b.a. Franck's Compounding Lab Sterility Nationwide
Should you stop taking Baclofen?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.