CLASS III Drug recall · Reported 12 Aug 2015 · FDA Enforcement Report
Panadol (acetaminophen) Extra Strength, 500 mg, a) recalled
GlaxoSmithkline Consmer Healthcare is recalling Panadol (acetaminophen) Extra Strength, 500 mg, a) (, distributed in Puerto Rico. The recall was initiated on 30 Jun 2015 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-1287-2015
- FDA event ID
- 71717
- Recalling firm
- GlaxoSmithkline Consmer Healthcare, Moon Township, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Jun 2015
- FDA classified
- 5 Aug 2015
- Reported
- 12 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 30 Jun 2015 | Recall initiated by company | |
| 5 Aug 2015 | Classified by FDA | +36 days |
| 12 Aug 2015 | 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
Failed Dissolution Specifications
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
Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080-7, NDC 0135-0135-03) and c) 100 count (UPC 1-03-53100-91090-6, NDC 0135-0135-04) bottles, Distributed by: GlaxoSmithKline Consumer Healthcare L.P, Moon Township, PA 15108
Where it was distributed
Puerto Rico and Virgin Islands
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
a) 13034 exp 10/31/15, 13222 and 13337 exp 11/30/15, 13611 and 13760 exp 2/29/15, 13953 exp 4/30/16, and 14542 exp 1/31/17; b) BT10114001 and BT10115001A exp 2/1/18, 13316 and 13438 exp 11/30/15 and 13880 exp 2/29/16; c) 13298 exp 11/30/15 and 13759 exp 4/30/16
Where was it sold?
Puerto Rico and Virgin Islands
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.
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