PainAway II — Class III drug recall D-0070-2022
Terminated recall by Ultra Seal Corporation, reported 2021-11-03, distributed nationwide. Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic
| Recall number | D-0070-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultra Seal Corporation, New Paltz, NY, United States |
| Recall initiated | 2021-10-13 |
| Classified | 2021-10-26 |
| Reported by FDA | 2021-11-03 |
| Terminated | 2022-03-28 |
| Distributed | Nationwide (US) |
| Quantity | 2,484,274 tablets |
| Reason classes | specification failure |
| Lot numbers | 21-DEC, 21-OCT, 22-OCT, 23-FEB, AK-1057, AK-9336, AK-9407, K-9860, K9406 |
Product
PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)
Reason for recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0070-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.