CLASS III Drug recall · Reported 11 Jul 2012 · FDA Enforcement Report
Imodium Multi-Symptom Relief Caplets recalled
Mcneil Consumer Healthcare, Div Of Mcneil-ppc is recalling Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg blister pack, distributed nationwide in the US. The recall was initiated on 17 May 2012 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-1404-2012
- FDA event ID
- 61872
- Recalling firm
- Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Fort Washington, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 May 2012
- FDA classified
- 2 Jul 2012
- Reported
- 11 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 17 May 2012 | Recall initiated by company | |
| 2 Jul 2012 | Classified by FDA | +46 days |
| 11 Jul 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container; damaged blister units
Product as listed by the FDA
Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Defective Container; damaged blister units
Which lots are affected?
Lot #CMF023, Expiration 07/13.
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 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 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.
More recalls from Mcneil Consumer Healthcare, Div Of Mcneil-ppc
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Concentrated Motrin (ibuprofen) Infants' Drops Oral recalled | Mcneil Consumer Healthcare, Div Of Mcneil-ppc | Particulate Matter | Nationwide |