Extra Strength Headache Relief — Class III drug recall D-1513-2020
Terminated recall by Ultra Seal Corporation, reported 2020-08-26, distributed in IL, TX. Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic
| Recall number | D-1513-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultra Seal Corporation, New Paltz, NY, United States |
| Recall initiated | 2020-08-03 |
| Classified | 2020-08-20 |
| Reported by FDA | 2020-08-26 |
| Terminated | 2021-03-16 |
| Distributed | IL, TX |
| Quantity | 701,735 packets |
| Reason classes | specification failure |
| Lot numbers | A9392, AK8909, AK9072, AK9102, AK9145, AK9276, AK9391, AK9505, AK9507, AK9508, AK9509, AK9601, AK9679, AK9743, AK9830, K-8909, K9145 |
| Expiration dates | 2020-12, 2021-03, 2021-04, 2021-05, 2021-06, 2021-07, 2021-09, 2021-12, 2022-02, 2022-04 |
Product
Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,
Reason for recall
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
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-1513-2020. 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.