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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.

Clear
DateProductReasonClassFirm
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 Sprycel 100 mg tablet NDC 00003-0852-22 30 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 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 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 2, 2018 WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dis... CGMP Deviations: finished products were manufactured with poor quality water. Class II Diamond Wipes International, Inc.
Apr 2, 2018 ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30... CGMP Deviations: finished products were manufactured with poor quality water. Class II Diamond Wipes International, Inc.
Mar 30, 2018 Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only,... Failed Dissolution Specifications Class II AVKARE Inc.
Mar 30, 2018 PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 g... Microbial Contamination of Non-Sterile Products Class II Marcas Usa Llc
Mar 29, 2018 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Pa... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 29, 2018 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Pa... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 29, 2018 Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-72... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 29, 2018 Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC ... CGMP Deviations: the product was produced with substandard GMP manufacturing processes. Class II United Pacific Co Ltd
Mar 28, 2018 Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), El... cGMP Deviations Class II Elroselabs Inc.
Mar 28, 2018 Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc. cGMP Deviations Class II Elroselabs Inc.
Mar 28, 2018 Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, M... cGMP Deviations Class II Elroselabs Inc.
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL pack... Superpotent Drug Class II Lupin Pharmaceuticals Inc.
Mar 27, 2018 Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL)... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administratio... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 22, 2018 Testosterone 40 mg pellet packaged in amber vial, Rx only, Partell Specialt... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, Rx only, Partell Speci... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 TM #4 (ALP 20/PAPAV/PHENT 2), 3 mL amber vial, Rx only, Partell Specialty Pha... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone/Estradiol 60 mg/6 mg pellet Amber vial, Rx only, Partell Special... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy

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.