Panadol Extra Strength Recall: Failed Dissolution Specs
GlaxoSmithKline recalls Panadol Extra Strength 500mg bottles in Puerto Rico and Virgin Islands due to failed dissolution specifications.
Use caution until it’s fixed
Failed Dissolution Specifications
Contact the company
What happened, in plain English
GlaxoSmithKline Consumer Healthcare is recalling specific lots of Panadol (acetaminophen) Extra Strength, 500 mg, because the tablets do not meet dissolution specifications. This means the medication may not release its active ingredient properly, potentially reducing its effectiveness for pain relief or fever reduction. The recall affects bottles distributed in Puerto Rico and the Virgin Islands. Read more at govinfonow.com/recall/44113-glaxosmithkline-consmer-healthcare-recalls-panadol-acetaminophen-extra-strength-500-mg.
Source Summary by GovInfoNow · govinfonow.com/recall/44113-glaxosmithkline-consmer-healthcare-recalls-panadol-acetaminophen-extra-strength-500-mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-1287-2015
Cite this page
“Panadol Extra Strength Recall: Failed Dissolution Specs.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44113-glaxosmithkline-consmer-healthcare-recalls-panadol-acetaminophen-extra-strength-500-mg. Based on FDA recall #D-1287-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1287-2015%22&limit=1).
Why it’s dangerous
The recalled tablets failed dissolution specifications, which is a quality control test ensuring the drug breaks down and releases its active ingredient in the body at the correct rate. If the tablets do not dissolve properly, the acetaminophen may not be absorbed effectively, leading to inadequate pain relief or fever reduction when the consumer expects it.
Who’s affected
Consumers in Puerto Rico and the Virgin Islands who purchased Panadol Extra Strength 500 mg bottles with the specific lot numbers and expiration dates listed below. Individuals relying on this medication for pain or fever relief may receive a product that does not work as intended.
How to tell if you have this one
Check your Panadol Extra Strength, 500 mg bottles for the following details: - Brand: Panadol - Product: Extra Strength, 500 mg - Distributor: GlaxoSmithKline Consumer Healthcare L.P., Moon Township, PA - Lot Numbers and Expiration Dates: - 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02): Lots 13034 (exp 10/31/15), 13222 (exp 11/30/15), 13337 (exp 11/30/15), 13611 (exp 2/29/15), 13760 (exp 2/29/15), 13953 (exp 4/30/16), 14542 (exp 1/31/17) - 60 count (UPC 1-03-53100-91080-7, NDC 0135-0135-03): Lots BT10114001 (exp 2/1/18), BT10115001A (exp 2/1/18), 13316 (exp 11/30/15), 13438 (exp 11/30/15), 13880 (exp 2/29/16) - 100 count (UPC 1-03-53100-91090-6, NDC 0135-0135-04): Lots 13298 (exp 11/30/15), 13759 (exp 4/30/16)
- Brand
Panadol- Product
Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your Panadol Extra Strength bottle matches the lot numbers and expiration dates listed in the recall details.
Stop Using Recalled Product
If you have a recalled bottle, stop using it immediately as it may not provide effective pain relief or fever reduction.
Contact Manufacturer for Remedy
The recall record does not specify the remedy or return instructions; please contact GlaxoSmithKline Consumer Healthcare directly for further guidance on how to proceed with your specific lot.
Where it went and when
Where it was distributed
Distributed in Puerto Rico.
FDA distribution: “Puerto Rico and Virgin Islands” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Puerto Rico.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1287-2015 (June 30, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1287-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.