Isopto Carpine Recall: Failed Impurity Specs
Novartis recalls Isopto Carpine 4% eye drops due to failed impurity specifications. Check lot 244661F, exp Feb 2018.
Recall notice
Failed Impurities/Degradation Specifications.
Contact the company
What happened, in plain English
Novartis Pharmaceuticals Corp. is recalling Isopto Carpine (pilocarpine hydrochloride ophthalmic solution) 4%. The product was recalled because it failed impurity and degradation specifications. This specific batch was distributed nationwide. Read more at govinfonow.com/recall/41792-isopto-carpine-recall-failed-impurity-specs.
Source Summary by GovInfoNow · govinfonow.com/recall/41792-isopto-carpine-recall-failed-impurity-specs · Updated October 11, 2026 · FDA enforcement record: FDA #D-0678-2017
Cite this page
“Isopto Carpine Recall: Failed Impurity Specs.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41792-isopto-carpine-recall-failed-impurity-specs. Based on FDA recall #D-0678-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0678-2017%22&limit=1).
Why it’s dangerous
The product failed impurity and degradation specifications, meaning it may contain unexpected substances or have degraded beyond acceptable limits. The record does not specify the exact health risks associated with these failed specifications.
Who’s affected
Patients who purchased or were prescribed Isopto Carpine 4% eye drops in 15 mL bottles between the manufacturing date and February 2018 are affected. The recall is nationwide, so anyone with this specific lot number may be impacted.
How to tell if you have this one
Look for Isopto Carpine (pilocarpine hydrochloride ophthalmic solution) 4% in a 15 mL bottle. Check the label for NDC 0998-0206-15 and Lot # 244661F with an expiration date of February 2018.
- Brand
Isopto- Category
Drug
All 2 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
| Recall number | Product, codes & lots | NDC |
|---|---|---|
| D-0678-2017 | Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15; Lot #: 244661F, Exp. Feb 2018 | — |
| D-0679-2017 | Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15; Lot #: 244660F, Exp. FEB 2018 | 61314-203-15, 61314-204-15, 61314-206-15 |
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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
Where was this product sold?
The distribution pattern for this recall is nationwide.
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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-0678-2017 (March 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0678-2017 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.