Advance Formula Pain Reliever — Class III drug recall D-0075-2022
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-0075-2022 |
|---|---|
| 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 | 991,310 tablets |
| Reason classes | specification failure |
| Lot numbers | 22-DEC, 22-JAN, 22-MAR, 23-JAN, AK-1017, AK-9457, AK-9521, AK-9959 |
| Model numbers | 1170 |
Product
Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (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-0075-2022. 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.