Xpect First aid Extra Strength PAIN AWAY — Class III drug recall D-0076-2022
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-0076-2022 |
|---|---|
| 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 | 42,394,018 tablets |
| Reason classes | specification failure |
| Lot numbers | 10/21, 1014, 1055, 1057, 1240, 21-DEC, 21-OCT, 22-APR, 22-AUG, 22-DEC, 22-FEB, 22-JAN, 22-JUL, 22-JUN, 22-MAR, 22-MAY, 22-OCT, 22-SEP, 23-FEB, 23-JAN, 23-JUL, 23-JUN, 23-MAY, 9455, 9718, AK-1011, AK-1058, AK-1108, AK-1113, AK-1199, AK-1240, AK-1278, AK-9335, AK-9369, AK-9403, AK-9406, AK-9419, AK-9452, AK-9489, AK-9525 and 27 more |
Product
Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, 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-0076-2022. 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.