CLASS II Drug recall · Reported 20 Jan 2016 · FDA Enforcement Report
Domperidone BP, Active Pharmaceutical Ingredient recalled
Freedom Pharmaceuticals is recalling Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, distributed nationwide in the US. The recall was initiated on 10 Mar 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-0567-2016
- FDA event ID
- 72795
- Recalling firm
- Freedom Pharmaceuticals, Broken Arrow, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2015
- FDA classified
- 12 Jan 2016
- Reported
- 20 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Compounded Drugs
Timeline
| 10 Mar 2015 | Recall initiated by company | |
| 12 Jan 2016 | Classified by FDA | +308 days |
| 20 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
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
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
Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
Which lots are affected?
Lot #: F10349, F10349A, F10349B, F10349C, F10349D, F10349E, Exp 01/15; F10829, F10829A, F10829B, F10829C, F10829-2, F10829-2A, F10829-2B, F10829-2D, F10829-2E, F10829-3, F10829-3A, F10829-3B, F10829-3C, F10829-3D, Exp 01/17; F11035, F11035A, F11035B, F11035C, Exp 08/17
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 | Baclofen USP powder recalled by Freedom Pharmaceuticals | Freedom Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | 5-methyltetrahydrofolate Calcium (L) (a) 1 gm in container recalled | Freedom Pharmaceuticals | Potency & Assay | Nationwide |