CLASS II Drug recall · Reported 9 Jul 2014 · FDA Enforcement Report
Diphenhydramine (Alcohol Base) 25 mg / Solution recalled
Brookfield Prescription Center is recalling Diphenhydramine (Alcohol Base) 25 mg / Solution, distributed in Wisconsin. The recall was initiated on 30 May 2014 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-1417-2014
- FDA event ID
- 68616
- Recalling firm
- Brookfield Prescription Center, Brookfield, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 May 2014
- FDA classified
- 3 Jul 2014
- Reported
- 9 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Drug class
- Allergy Medication
Timeline
| 30 May 2014 | Recall initiated by company | |
| 3 Jul 2014 | Classified by FDA | +34 days |
| 9 Jul 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Product as listed by the FDA
Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Where it was distributed
WI only
Questions about this recall
Is Diphenhydramine (Alcohol Base) 25 mg / Solution recalled?
Yes. Brookfield Prescription Center recalled Diphenhydramine (Alcohol Base) 25 mg / Solution on 30 May 2014. The recall is Class II and its status is Terminated. Recall number D-1417-2014.
Why was it recalled?
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Which lots are affected?
Lot # / Beyond Use Date: 05012014@36 / 05/15/14
Where was it sold?
WI only
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.