FDA Drug recall D-0077-2022
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged i…
- FDA Drug
- Class III
- terminated
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class III recall of Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged i… by Ultra Seal, citing failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0077-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-10-13 |
| Published | 2021-11-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ultra Seal |
| Distribution | US |
Product
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)
Reason
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Identifiers
| code_info | Lot #: 9819, K-9819, exp. date 22-Sep |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0077-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.