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Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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DateProductReasonClassFirm
Apr 5, 2018 LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bio... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
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 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.
Apr 3, 2018 Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04 Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply. Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vit... Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Botox 100 Units Vial NDC 00023-1145-01 90 days supply. Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply. Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply. Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply. Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Ibrance 125 mg cap NDC 00069-0189-21 28 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.