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Browse Drug Recalls

67 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 67 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 67 FDA drug recalls.

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DateProductReasonClassFirm
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 Temozolomide 20 mg NDC 43975-0253-05 28 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 Xalkori 250 mg cap NDC 00069-8140-20 30 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 Capecitabine 150 mg Tablet NDC 00378-2511-91 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 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 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 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 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 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 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 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 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 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 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 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 Promacta 50 mg tablet NDC 00078-0686-15 30 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 Temozolomide 250 mg NDC 43975-0257-05 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 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 Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 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.
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 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 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 Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 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 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 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 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 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 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 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 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 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 Botox 100 Units Vial NDC 00023-1145-01 90 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 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 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 Sprycel 80 mg tablet NDC 00003-0855-22 30 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 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 Dexamethasone 4 mg tablet NDC 49884-0087-01 28 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.