Browse Drug Recalls
15 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 15 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 15 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 12, 2023 | Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 va... | cGMP deviations: potential for Microbial Contamination of Non-Sterile Products | Class II | Ferring Pharmaceuticals Inc |
| Apr 19, 2023 | Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Ster... | Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. | Class II | Sun Pharmaceutical Industries Ltd. |
| Apr 13, 2022 | Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), package... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Mar 11, 2021 | ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACT... | Defective Delivery System: customer complaints concerning the injector pen breaking apart and dis... | Class II | Ferring Pharmaceuticals Inc |
| Mar 11, 2021 | ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMAC... | Defective Delivery System: customer complaints concerning the injector pen breaking apart and dis... | Class II | Ferring Pharmaceuticals Inc |
| Mar 2, 2021 | Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vial... | Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP | Class III | Ferring Pharmaceuticals Inc |
| Jul 21, 2020 | DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only... | Superpotent Drug | Class I | Ferring Pharmaceuticals Inc |
| Jul 21, 2020 | Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap... | Superpotent Drug | Class I | Ferring Pharmaceuticals Inc |
| Jul 21, 2020 | STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with s... | Superpotent Drug | Class I | Ferring Pharmaceuticals Inc |
| Sep 9, 2015 | Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or I... | Subpotent Drug | Class III | Ferring Pharmaceuticals Inc |
| Apr 28, 2014 | TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bott... | Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone ... | Class II | Ferring Pharmaceuticals Inc |
| Sep 19, 2013 | ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Man... | Discoloration; due to prolonged heat exposure. | Class III | Ferring Pharmaceuticals Inc |
| Feb 1, 2013 | TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescripti... | Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Fre... | Class III | Ferring Pharmaceuticals Inc |
| Aug 23, 2012 | Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUS... | Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warn... | Class III | Ferring Pharmaceuticals 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.