CLASS II Drug recall · Reported 2 Mar 2022 · FDA Enforcement Report
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg recalled
Perrigo Company is recalling Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/ per, distributed nationwide in the US. The recall was initiated on 26 Oct 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0597-2022
- FDA event ID
- 88905
- Recalling firm
- Perrigo Company, Allegan, MI
- Manufacturer
- Wal-Mart Stores Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Oct 2021
- FDA classified
- 23 Feb 2022
- Reported
- 2 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 26 Oct 2021 | Recall initiated by company | |
| 23 Feb 2022 | Classified by FDA | +120 days |
| 2 Mar 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Product as listed by the FDA
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentoneville, AR 72716. NDC: 49035-766-16
Where it was distributed
Nationwide in the USA
Stores named: Walmart
Questions about this recall
Is Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/ per recalled?
Yes. Perrigo Company recalled Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/ per on 26 Oct 2021. The recall is Class II and its status is Terminated. Recall number D-0597-2022.
Why was it recalled?
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Which lots are affected?
Batch: 1CK1274, Exp 02/28/2023
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Perrigo Company
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|---|---|---|---|---|---|
| Drug | CLASS II | Children's Pain & Fever Acetaminophen recalled by Perrigo Company | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Children's Cherry Flavored Acetaminophen Oral Suspension (160mg recalled | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nasal Spray Decongestant, No Drip, Oxymetazoline HCl recalledNasal | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen Oral Suspension Grape Flavor, 160 mg recalled | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Maximum Strength Nasal Spray recalled by Perrigo CompanyNasal | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
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|---|---|---|---|---|---|
| Drug | CLASS II | Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength | Kenvue Brands | Other | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen | Hikma Pharmaceuticals USA | Packaging Defects | OH, PR |
| Drug | CLASS I | Acetaminophen Extra Strength Tablets, 500 mg each recalledAcetaminophen | A-S Medication Solutions | Labeling Errors | Nationwide |