Browse Drug Recalls
6 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 6 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 19, 2015 | HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001... | Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... | Class III | Oasis Medical, Inc. |
| Oct 19, 2015 | HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL ... | Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... | Class III | Oasis Medical, Inc. |
| Oct 19, 2015 | HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe,... | Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... | Class III | Oasis Medical, Inc. |
| Aug 31, 2015 | ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe... | Falied pH specification | Class III | Oasis Medical, Inc. |
| Apr 10, 2015 | ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe... | Failed pH specification | Class III | Oasis Medical, Inc. |
| May 14, 2014 | Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distribu... | Labeling: Missing Label; The label on the immediate bottle is missing. | Class III | Oasis Medical Inc |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.