CLASS III Drug recall · Reported 3 Apr 2013 · FDA Enforcement Report
PE Daytime Cold/Flu LiqGel, Multi Symptom Relief recalled by L. Perrigo
L. Perrigo is recalling PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan, distributed in Arkansas. The recall was initiated on 18 Feb 2013 and the FDA has classified it as Class III.
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-216-2013
- FDA event ID
- 64388
- Recalling firm
- L. Perrigo, Allegan, MI
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Feb 2013
- FDA classified
- 22 Mar 2013
- Reported
- 3 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 18 Feb 2013 | Recall initiated by company | |
| 22 Mar 2013 | Classified by FDA | +32 days |
| 3 Apr 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716
Where it was distributed
Walmart Distribution Center in Bentonville, AR
Stores named: Walmart
Questions about this recall
Why was it recalled?
Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.
Which lots are affected?
2 AE1549 Exp. 02/13
Where was it sold?
Walmart Distribution Center in Bentonville, AR
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 L. Perrigo
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg recalledExchange Select Aller Ease | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy Aller-fex, Fexofenadine Hydrochloride Tablets, 180 mg recalledKirkland Signature Aller Fex | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride recalledBerkley Jensen Allergy Relief | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy, Fexofenadine Hydrochloride Tablets, 180 mg recalledBasic Care Allergy | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine recalled | L. Perrigo | Potency & Assay | Nationwide |