Akorn Recalls Chlorhexidine Oral Rinse Due to Impurities
Akorn recalls specific lots of Chlorhexidine gluconate oral rinse (0.12%) due to failed impurity specifications. Check your bottle's lot number and expiration date.
Recall notice
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Contact the company
What happened, in plain English
Akorn, Inc. is recalling Chlorhexidine gluconate oral rinse, 0.12%, packaged in 16 fl. oz. PET bottles. The recall is necessary because multiple batches failed to meet specifications for unknown impurities or degradation products. The record does not specify a remedy or what consumers should do with the product. Read more at govinfonow.com/recall/43100-akorn-recalls-chlorhexidine-oral-rinse-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/43100-akorn-recalls-chlorhexidine-oral-rinse-due-to-impurities · Updated October 11, 2026 · FDA enforcement record: FDA #D-0875-2016
Cite this page
“Akorn Recalls Chlorhexidine Oral Rinse Due to Impurities.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43100-akorn-recalls-chlorhexidine-oral-rinse-due-to-impurities. Based on FDA recall #D-0875-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0875-2016%22&limit=1).
Why it’s dangerous
The recalled product contains out-of-specification results for an unknown impurity of Chlorhexidine gluconate. The specific health risks or injury mechanisms associated with this impurity are not described in the provided record.
Who’s affected
Consumers who purchased Chlorhexidine gluconate oral rinse, 0.12%, from pharmacies nationwide or in Puerto Rico between the manufacturing dates and the recall date of March 23, 2016. The record does not specify which health conditions these products were prescribed for.
How to tell if you have this one
Check your bottle for the following details: Brand/Manufacturer 'Akorn, Inc.' (Manufactured by HI-TECH PHARMACAL CO., INC.), NDC 5083-0720-16, and a lot number from the list below. The product is a prescription-only oral rinse in a 16 fl. oz. (473 mL) PET bottle.
- Brand
Akorn- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0874-2016 | ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O; Lot # 628146, Exp 6/16; 629690, Exp 9/16; 348295, Exp 10/17 | 33,862 mL |
| D-0875-2016 | Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16; Lot # 627528, 627763, 627766, 627921, 627924, 627927, 627930, 627933, 627953, 627956, 627959, 628040, Exp 5/16; 628148, 628151, 628230, 628232, 628365, Exp 6/16; 628589 , 628592, 628598, 628802, 628805, 628808, 628811, 628814, Exp 7/16 ; 629059, 629204, 629207, 629232, 629235, 629307, 629310, 629313, 629316, Exp 8/16; 629687, 629693, 629696, 629882, 629888, 630058, Exp 9/16; 630061, 630064, 630221, 630224, 630362, 630365, 630613, Exp 10/16; 630615, 630732, 630735, 630853, 630856, 630859, 631008, Exp 11/16; 631026, 631027, 631169, 631172, 631175, 631655, 631658, Exp 12/16; 631704, 631707, 631861, 631864, 631867, 632059, 632062, 632065, 632068, 632071, 632074, 632211, 632214 Exp 1/17; 632328, 632331, 632334, 632337, 632472, 632475, 632504, 632507, 632697, Exp 2/17; 633090, 633093, 632776, 632781, 632784, 632790, 632793, 632796, 632805, 632808, 632811, 632814, 633072, 633078, 633081, 633084, 633087, Exp 3/17; 633681, 633682, 633099, 633684, 633111, Exp 4/17; 345607, 345618, 345620, Exp 5/17; 346575, 346863, 346571, 346720,3 46573, Exp 7/17 | 3,112,657 mL |
| D-0876-2016 | PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701; Lot # 627525, Exp 5/16; 628362, Exp 6/16; 628595, Exp 7/16; 629319, Exp 8/16; 629885, Exp 9/16; 630467,Exp10/16; 32218, 632500, Exp 2/17; 633075, 632799, Exp 3/17; 345624, 345679, Exp 5/17; 347420, 347662, Exp 9/17 | 294,090 mL |
What to do — step by step
Check Your Lot Number
Compare the lot number on your bottle against the recalled lots listed in the record to see if it is included in this recall.
Contact Your Pharmacist
Since the product is Rx only and no specific remedy is stated, consult your pharmacist or healthcare provider for guidance on what to do with the product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Which lot numbers are recalled?
Recalled lots include: 627528, 627763, 627766, 627921, 627924, 627927, 627930, 627933, 627953, 627956, 627959, 628040 (Exp 5/16); 628148, 628151, 628230, 628232, 628365 (Exp 6/16); 628589, 628592, 628598, 628802, 628805, 628808, 628811, 628814 (Exp 7/16); 629059, 629204, 629207, 629232, 629235, 629307, 629310, 629313, 629316 (Exp 8/16); 629687, 629693, 629696, 629882, 629888, 630058 (Exp 9/16); 630061, 630064, 630221, 630224, 630362, 630365, 630613 (Exp 10/16); 630615, 630732, 630735, 630853, 630856, 630859, 631008 (Exp 11/16); 631026, 631027, 631169, 631172, 631175, 631655, 631658 (Exp 12/16); 631704, 631707, 631861, 631864, 631867, 632059, 632062, 632065, 632068, 632071, 632074, 632211, 632214 (Exp 1/17); 632328, 632331, 632334, 632337, 632472, 632475, 632504, 632507, 632697 (Exp 2/17); 633090, 633093, 632776, 632781, 632784, 632790, 632793, 632796, 632805, 632808, 632811, 632814, 633072, 633078, 633081, 633084, 633087 (Exp 3/17); 633681, 633682, 633099, 633684, 633111 (Exp 4/17); 345607, 345618, 345620 (Exp 5/17); 346575, 346863, 346571, 346720, 346573 (Exp 7/17).
What is the NDC number for this product?
The National Drug Code (NDC) for the recalled product is 5083-0720-16.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0875-2016 (March 23, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0875-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.