Browse Drug Recalls
3 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3 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 3 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 30, 2020 | Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) S... | Labeling: Missing instructions for use insert | Class II | Allergan, PLC. |
| Dec 20, 2018 | OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic ap... | GMP Deviations: A silicone particulate was noted in Ozurdex. | Class II | Allergan, PLC. |
| May 24, 2018 | Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians... | Contraceptive Tablets Out of Sequence. | Class I | Allergan, PLC. |
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.