Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Nov 9, 2015 (11 years ago)

Baclofen USP powder

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Foreign Substance

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

What was recalled

Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d) 52372-0909-10.

Affected NDCs 52372-0909-01 52372-0909-10 52372-0909-25 52372-0909-50

Compare with the code on your package — it is the most precise check available.

Drug: Baclofen

Recalling firm
Freedom Pharmaceuticals Inc
Origin
OK, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0573-2016 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Baclofen recalls

See all

Other recalls by Freedom Pharmaceuticals Inc

All 2015 recalls
Class II · Moderate risk

Domperidone BP

Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.

Terminated Cross-contamination Freedom Pharmaceuticals Inc D-0567-2016