Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 5, 2018 | LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., S... | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Class II | Coastal Meds, LLC. |
| Apr 5, 2018 | LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C ... | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Class II | Coastal Meds, LLC. |
| Apr 5, 2018 | PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C... | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Class II | Coastal Meds, LLC. |
| Apr 5, 2018 | ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste ... | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Class II | Coastal Meds, LLC. |
| Apr 5, 2018 | LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.,... | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Class II | Coastal Meds, LLC. |
| Apr 5, 2018 | METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., ... | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Class II | Coastal Meds, LLC. |
| Apr 5, 2018 | LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C B... | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Class II | Coastal Meds, LLC. |
| Apr 5, 2018 | HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr.... | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Class II | Coastal Meds, LLC. |
| Apr 5, 2018 | CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., ... | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Class II | Coastal Meds, LLC. |
| Apr 3, 2018 | Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply. | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Temozolomide 250 mg NDC 43975-0257-05 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Promacta 50 mg tablet NDC 00078-0686-15 30 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days sup... | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply. | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30 | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply; | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Xalkori 250 mg cap NDC 00069-8140-20 30 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Temozolomide 20 mg NDC 43975-0253-05 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98 | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply. | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply. | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Ki... | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Otezla 30 mg tablet NDC 59572-0631-06 30 days supply; | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Altera Handset NDC 83490-0678-05 56 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-020... | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply. | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Xolair 150 mg SDV NDC 50242-0040-62 28 days | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, Inc. |
| Apr 3, 2018 | Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply | Lack of Processing Controls. | Class II | Kroger Specialty Pharmacy, 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.