Pilocarpine Hydrochloride Ophthalmic Solution 4% — Class III drug recall D-0679-2017
Terminated recall by Novartis Pharmaceuticals Corp., reported 2017-05-03, distributed nationwide. Failed Impurities/Degradation Specifications.
| Recall number | D-0679-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Pharmaceuticals Corp., East Hanover, NJ, United States |
| Recall initiated | 2017-03-22 |
| Classified | 2017-04-21 |
| Reported by FDA | 2017-05-03 |
| Terminated | 2020-02-05 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 61314-0203, 61314-0203-15, 61314-0204, 61314-0204-15, 61314-0206, 61314-0206-15 |
| Lot numbers | 244660F |
| Expiration dates | 2018-02-20 |
Product
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
Reason for recall
Failed Impurities/Degradation Specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0679-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.