Hauppauge, NY, United States
LNK International, Inc. recalls
5 recalls recorded since 2018, most recently on 14 November 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 14 November 2024
- Terminated
- 2 September 2025
- Reason
- CGMP Deviations: Released product should have been rejected.
- Distribution
- Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0115-2025
- Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (A
Terminated Class III Drugs
- Recall started
- 11 October 2022
- Terminated
- 25 July 2023
- Reason
- Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0014-2023
- NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestan
Terminated Class III Drugs
- Recall started
- 4 August 2022
- Terminated
- 3 March 2023
- Reason
- Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
- Distribution
- Product was distributed to one retailer who may have further distributed the product to other distribution sites nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1472-2022
- Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.
Terminated Class III Drugs
- Recall started
- 7 July 2021
- Terminated
- 4 May 2023
- Reason
- Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
- Distribution
- Distributed in PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0665-2021
- Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71
Terminated Class II Drugs
- Recall started
- 10 July 2019
- Terminated
- 9 June 2023
- Reason
- Microbial contamination of non-sterile product
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1630-2019
- Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.