Sandoz Inc recalls Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured
Sandoz recalls Neomycin and Polymyxin B Sulfates with Dexamethasone ophthalmic suspension due to incorrect or missing package inserts. This affects specific 5mL bottles manufactured in 2019-2021.
Lower-risk recall
Labeling: Incorrect or missing package insert.
Contact the company & request your remedy
What happened, in plain English
Sandoz has recalled certain ophthalmic suspension products because they may have incorrect or missing package inserts. This could lead to improper use if the instructions are not clear. Patients should check their product details and contact the manufacturer if unsure. Read more at govinfonow.com/recall/37829-sandoz-ophthalmic-suspension-recall-missing-package-insert.
Source Summary by GovInfoNow · govinfonow.com/recall/37829-sandoz-ophthalmic-suspension-recall-missing-package-insert · Updated October 5, 2026 · FDA enforcement record: FDA #D-0162-2020
Cite this page
“Sandoz Ophthalmic Suspension Recall: Missing Package Insert.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37829-sandoz-ophthalmic-suspension-recall-missing-package-insert. Based on FDA recall #D-0162-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0162-2020%22&limit=1).
Why it’s dangerous
The product may have incorrect or missing package inserts, which could lead to improper use if the instructions are not clear. This is a labeling issue that does not involve immediate safety risks like injury or death.
Who’s affected
Prescription eye drop users who have the specific 5mL bottles with the listed lot numbers and expiration dates. Those with the product may be at risk if they use it without clear instructions.
How to tell if you have this one
Check for the 5mL bottle with the product name 'Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile'. Look for the specific lot numbers and expiration dates listed in the recall notice.
- Brand
Sandoz- 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 III- Status
Terminated- Distribution
Nationwide in the U.S.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0161-2020 | Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.; Lot #s: a) 290635FA, 290635FB, Exp. 11/30/2019; 293230F, Exp. 6/30/2020; 294628F, 301337F, Exp. 11/30/2020; 304451FA, Exp. 1/31/2021. b) 290636FA, 290636FB, 290636FC, Exp. 11/30/2019; 293233FA, 293233FB, Exp. 5/31/2020; 293234FA, 293234FB, Exp. 6/30/2020; 294630F, 301338FA, 301338FB, 309426F, Exp. 11/30/2020; 304455FA, 304455FB Exp. 2/28/2021; 304883F, Exp. 4/30/2021; 312790F, Exp. 5/31/2021. | 346,929 bottles | 0781-6206-75, 0781-6206-93 |
| D-0162-2020 | Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06; Lot #s: 287880F, 287881F, Exp. 10/31/2019; 290555F, Exp. 11/30/2019; 293389F, Exp. 2/29/2020; 290556F, 290557F, 293386F, 293387F, Exp. 3/31/2020; 293388F, 293390F, Exp. 5/31/2020; 293391F, Exp. 6/30/2020; 293392F, Exp. 7/31/2020; 295342F, 298823F, Exp. 8/31/2020; 295344F, 295345F, 295346F, Exp. 10/31/2020; 295347F, 304496F, Exp. 11/30/2020; 298825F, Exp. 12/31/2020; 304495F, 304497F, Exp. 01/31/2021; 304963F, Exp. 3/31/2021; 304966F, Exp. 4/30/2021; 304964F, Exp. 5/31/2021. | 346,929 bottles | 61314-630-06 |
| D-0163-2020 | Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.; Lot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020 | 76,644 bottles | 61314-672-25 |
What to do — step by step
Check Product Details
Look for the 5mL bottle with the product name and specific lot numbers listed in the recall notice.
Questions people ask
Is this product dangerous if used correctly?
The recall is for labeling issues, not safety risks. The product is safe if used as directed with proper instructions.
How do I know if my product is affected?
Check the lot number and expiration date on the bottle against the list provided in the recall notice.
Do I need to stop using this product?
No, the recall does not require stopping use. The issue is with labeling, not the product's safety.
Contact Sandoz
We’ve drafted a message you can send Sandoz to request your refund or repair — edit it as you like.
Subject: Recall D-0162-2020 — Sandoz Sandoz Hello, I own a Sandoz that is covered by recall D-0162-2020 from Sandoz. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0162-2020 (October 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0162-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.