CLASS III Drug recall · Reported 3 Nov 2021 · FDA Enforcement Report
North by Honeywell Pain Stopper Extra Strength recalled by Ultra Seal
Ultra Seal is recalling North by Honeywell Pain Stopper Extra Strength (Acetaminophen 250 mg, Aspirin 250 mg, distributed nationwide in the US. The recall was initiated on 13 Oct 2021 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-0074-2022
- FDA event ID
- 88843
- Recalling firm
- Ultra Seal, New Paltz, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Oct 2021
- FDA classified
- 26 Oct 2021
- Reported
- 3 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 13 Oct 2021 | Recall initiated by company | |
| 26 Oct 2021 | Classified by FDA | +13 days |
| 3 Nov 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
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
North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Which lots are affected?
Lot #: AK-9371, exp. date 21-Nov
Where was it sold?
Nationwide in the USA.
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.
Other products in this recall event
7 other products · FDA event 88843This product is part of a recall event; the main page for the event is Advance Formula Pain Reliever recalled by Ultra Seal.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Advance Formula Pain Reliever recalled by Ultra Seal | Ultra Seal | Potency & Assay | Nationwide | |
| CLASS III | Afassco Pain Free Plus X-strength Pain Reliever recalled by Ultra Seal | Ultra Seal | Potency & Assay | Nationwide | |
| CLASS III | Vica-Cet Back Pain Relief (Acetaminophen 250 mg/Aspirin recalled | Ultra Seal | Potency & Assay | Nationwide | |
| CLASS III | ZEE+ painaid ESF Extra-Strength Formula recalled by Ultra Seal | Ultra Seal | Potency & Assay | Nationwide | |
| CLASS III | Aero Tab Pain Reliever (Acetaminophen 250 mg/Aspirin recalled | Ultra Seal | Potency & Assay | Nationwide | |
| CLASS III | Xpect First aid Extra Strength Pain Away recalled by Ultra Seal | Ultra Seal | Potency & Assay | Nationwide | |
| CLASS III | PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine recalled | Ultra Seal | Potency & Assay | Nationwide |
More recalls from Ultra Seal
All 66| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Multi-Symptom Cramp Relief (acetaminophen 325mg recalled by Ultra Seal | Ultra Seal | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Electrolyte Supplement Tablets (calcium 5.2 mg recalled by Ultra Seal | Ultra Seal | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cetafen Cough & Cold Cough & Cold Relief recalled by Ultra Seal | Ultra Seal | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets recalled | Ultra Seal | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sinus Decongestant Nasal Decongestant recalled by Ultra Seal | Ultra Seal | Manufacturing (CGMP) Deviations | Nationwide |