CLASS III Drug recall · Reported 26 Aug 2020 · FDA Enforcement Report
Pain Relief Maximum Strength recalled by Ultra Seal
Ultra Seal is recalling Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, distributed in Illinois, Texas. The recall was initiated on 3 Aug 2020 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-1512-2020
- FDA event ID
- 86264
- Recalling firm
- Ultra Seal, New Paltz, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Aug 2020
- FDA classified
- 20 Aug 2020
- Reported
- 26 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 3 Aug 2020 | Recall initiated by company | |
| 20 Aug 2020 | Classified by FDA | +17 days |
| 26 Aug 2020 | Published in enforcement report | +6 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 (OOS) results for the Aspirin related compound Salicylic Acid was observed.
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
Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
Where it was distributed
Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
Questions about this recall
Is Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets recalled?
Yes. Ultra Seal recalled Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets on 3 Aug 2020. The recall is Class III and its status is Terminated. Recall number D-1512-2020.
Why was it recalled?
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Which lots are affected?
Lot #: AK8745, Exp. Date 08/20; AK9751, Exp. Date 08/2021; AK9552, Exp. Date 04/2022
Where was it sold?
Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
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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|---|---|---|---|---|---|
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