CLASS III Drug recall · Reported 8 May 2013 · FDA Enforcement Report
Cherry Cepacol Sore Throat Lozenges recalled by Reckitt Benckiser
Reckitt Benckiser is recalling Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 6 mg, a), distributed nationwide in the US. The recall was initiated on 18 Mar 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-310-2013
- FDA event ID
- 64652
- Recalling firm
- Reckitt Benckiser, Parsippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Mar 2013
- FDA classified
- 1 May 2013
- Reported
- 8 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cold & Cough Medicine
Timeline
| 18 Mar 2013 | Recall initiated by company | |
| 1 May 2013 | Classified by FDA | +44 days |
| 8 May 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
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
Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054
Where it was distributed
Nationwide
Questions about this recall
Is Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 6 mg, a) recalled?
Yes. Reckitt Benckiser recalled Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 6 mg, a) on 18 Mar 2013. The recall is Class III and its status is Terminated. Recall number D-310-2013.
Why was it recalled?
Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
Which lots are affected?
16 count: AG156 Exp 11/13, AG257 Exp 12/13, AH388 02/14, AJ167 03/14, AL367 Exp 05/14, AL555 & AL568 Exp 06/14, AM141 Exp 07/14. 576 Count: AK505 Exp 04/14, AK570 Exp 05/14, AH368 & AH398 Exp 02/14, AJ000 Exp 03/14, AG596 Exp 12/13,
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.
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