CLASS III Drug recall · Reported 3 May 2017 · FDA Enforcement Report
Isopto Carpine (pilocarpine hydrochloride opthalmic solution) recalled
Novartis Pharmaceuticals is recalling Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, distributed nationwide in the US. The recall was initiated on 22 Mar 2017 and the FDA has classified it as Class III.
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-0678-2017
- FDA event ID
- 76756
- Recalling firm
- Novartis Pharmaceuticals, East Hanover, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Mar 2017
- FDA classified
- 21 Apr 2017
- Reported
- 3 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 22 Mar 2017 | Recall initiated by company | |
| 21 Apr 2017 | Classified by FDA | +30 days |
| 3 May 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications.
Which lots are affected?
Lot #: 244661F, Exp. Feb 2018
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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
1 other product · FDA event 76756| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Pilocarpine Hydrochloride Ophthalmic Solution recalledPilocarpine Hydrochloride | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
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