Acetaminophen — Class I drug recall D-0358-2021
Terminated recall by A-S Medication Solutions LLC., reported 2021-05-12, distributed nationwide. Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included
| Recall number | D-0358-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | A-S Medication Solutions LLC., Libertyville, IL, United States |
| Recall initiated | 2021-03-02 |
| Classified | 2021-04-30 |
| Reported by FDA | 2021-05-12 |
| Terminated | 2025-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 201,600 kits |
| Reason classes | labeling, potency |
| NDC | 50090-5350, 50090-5350-00, 50090-5350-01 |
| Lot numbers | 323206, 323207, 323208, 323209, 323210, 323211, 323212, 323213, 323214, 323215, 323216, 323218, 323219, 323220, 323222, 323223, 323224, 323238, 335353, 335354, 335355, 335356, 335358, 335359, 335360, 335361, 335362, 335363, 335364, 335365, 335366, 335367, 335368, 335369, 335370, 335371, 335372, 335373, 335374, 335375 and 4 more |
| Expiration dates | 2022-07-31, 2022-08-31 |
Product
Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152; Packaged Exclusively By: A-S Medication Solutions LLC, Libertyville, IL 60048, Product # 6967-0; NDC: 50090-5350-0; contained within Health Essentials Kit, Kit Contains: 1 bottle hand sanitzer, 1 reusable face mask, 1 bottle Acetaminophen 500 mg, 1 bag cough drops, 1 digital thermometer, 50 disposable gloves.
Reason for recall
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
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-0358-2021. 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.