CLASS II Drug recall · Reported 9 Feb 2022 · FDA Enforcement Report
Back Pain-Off (caffeine 50mg recalled by Ultra Seal
Ultra Seal is recalling Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets packets, distributed nationwide in the US. The recall was initiated on 24 Jan 2022 and the FDA has classified it as Class II.
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-0476-2022
- FDA event ID
- 89464
- Recalling firm
- Ultra Seal, New Paltz, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jan 2022
- FDA classified
- 31 Jan 2022
- Reported
- 9 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 24 Jan 2022 | Recall initiated by company | |
| 31 Jan 2022 | Classified by FDA | +7 days |
| 9 Feb 2022 | 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
cGMP deviations
Product as listed by the FDA
Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets packets recalled?
Yes. Ultra Seal recalled Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets packets on 24 Jan 2022. The recall is Class II and its status is Terminated. Recall number D-0476-2022.
Why was it recalled?
cGMP deviations
Which lots are affected?
Lot #: 9708, Exp. Date 07/2022; AK9810, Exp. Date 09/2022; AK9946, K9946, Exp. Date 12/2022
Where was it sold?
Nationwide within the United States
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 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 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 |