CLASS II Drug recall · Reported 27 Jan 2016 · FDA Enforcement Report
Baclofen USP powder recalled by Freedom Pharmaceuticals
Freedom Pharmaceuticals is recalling Baclofen USP powder, distributed nationwide in the US. The recall was initiated on 9 Nov 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0573-2016
- FDA event ID
- 72854
- Recalling firm
- Freedom Pharmaceuticals, Broken Arrow, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2015
- FDA classified
- 19 Jan 2016
- Reported
- 27 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
Timeline
| 9 Nov 2015 | Recall initiated by company | |
| 19 Jan 2016 | Classified by FDA | +71 days |
| 27 Jan 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance
Which lots are affected?
Lot #: F10918, F10918-2, Exp: 07/24/2016; F10867, F10867A, Exp date: 03/11/2016
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Freedom Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Domperidone BP, Active Pharmaceutical Ingredient recalled | Freedom Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | 5-methyltetrahydrofolate Calcium (L) (a) 1 gm in container recalled | Freedom Pharmaceuticals | Potency & Assay | Nationwide |
Other Baclofen recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Baclofen Tablets USP, 10 mg recalled by Golden State Medical SupplyBaclofen | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS II | Baclofen 2000MCG/ML INJ in syringe Assurance Infusion (713) recalled | Assurance Infusion | Sterility | Nationwide |
| Drug | CLASS II | Baclofen and Clonidine HCL and Morphine Sulfate recalled | Coast Quality Pharmacy | Packaging Defects | Nationwide |
| Drug | CLASS II | Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe recalledGablofen | Piramal Critical Care | Potency & Assay | Nationwide |
| Drug | CLASS II | Baclofen 5000 mcg/ml, vol recalled by Hartley Medical Center | Hartley Medical Center Pharmacy | Sterility | Nationwide |