CLASS II Drug recall · Reported 27 Nov 2013 · FDA Enforcement Report
Acetaminophen suspension liquid, 160 mg recalled by L. Perrigo
L. Perrigo is recalling Acetaminophen suspension liquid, 160 mg/, grape flavor bottle co-packaged with an oral, distributed nationwide in the US. The recall was initiated on 1 Nov 2013 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-006-2014
- FDA event ID
- 66711
- Recalling firm
- L. Perrigo, Allegan, MI
- Manufacturer
- Wal-Mart Stores Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Nov 2013
- FDA classified
- 20 Nov 2013
- Reported
- 27 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 1 Nov 2013 | Recall initiated by company | |
| 20 Nov 2013 | Classified by FDA | +19 days |
| 27 Nov 2013 | 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
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) equate Infants' Pain & Fever acetaminophen suspension liquid, Distributed by: Wal-Mart Stores, Inc., Bentonville, AZ 72716, NDC 49035-946-16, UPC 0 78742 09060 3; b) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-576-16, UPC 0 96295 12093 6; c) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-946-16, UPC 0 36800 34645 1; d) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0946-16, UPC 3 11917 13225 9; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-946-16, UPC 0 41260 35832 6
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Which lots are affected?
Lot #: 3JK0653, Exp 07/15; 3JK0433, Exp 07/15; 3KK0817, Exp 08/15; 3JK0673, Exp 08/15; 3KK0494, Exp 08/15; 3KK0360, Exp 08/15
Where was it sold?
Nationwide
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 66711This product is part of a recall event; the main page for the event is Acetaminophen suspension liquid, 160 mg recalled by L. Perrigo.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Acetaminophen suspension liquid, 160 mg recalled by L. PerrigoTopcare Infants Pain And Fever | L. Perrigo | Packaging Defects | Nationwide | |
| CLASS II | Acetaminophen suspension liquid, 160 mg recalled by L. PerrigoPain And Fever | L. Perrigo | Packaging Defects | Nationwide | |
| CLASS II | Acetaminophen suspension liquid, 160 mg recalled by L. PerrigoPain And Fever | L. Perrigo | Packaging Defects | Nationwide |
More recalls from L. Perrigo
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg recalledExchange Select Aller Ease | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy Aller-fex, Fexofenadine Hydrochloride Tablets, 180 mg recalledKirkland Signature Aller Fex | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride recalledBerkley Jensen Allergy Relief | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy, Fexofenadine Hydrochloride Tablets, 180 mg recalledBasic Care Allergy | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine recalled | L. Perrigo | Potency & Assay | Nationwide |
Other Acetaminophen recalls
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 II | Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion | LNK International | Manufacturing (CGMP) Deviations | Nationwide |