Browse Drug Recalls
8 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 8 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 8 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 19, 2024 | FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 19, 2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx ... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 19, 2024 | FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips pe... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 19, 2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx ... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 13, 2021 | Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein S... | Subpotent Drug | Class III | Nomax Inc |
| Mar 24, 2015 | Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL... | Failed Content Uniformity Specifications: The product may not meet finished product release speci... | Class III | Nomax Inc |
| Mar 24, 2015 | Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Flu... | Failed Content Uniformity Specifications: The product may not meet finished product release speci... | Class III | Nomax Inc |
| Mar 24, 2015 | Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, ... | Failed Content Uniformity Specifications: The product may not meet finished product release speci... | Class III | Nomax 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.