DL DrugLabelsHubFDA Drug Label Lookup

FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply. Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply. Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply. Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply. Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Botox 100 Units Vial NDC 00023-1145-01 90 days supply. Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply; Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Altera Handset NDC 83490-0678-05 56 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Otezla 30 mg tablet NDC 59572-0631-06 30 days supply; Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04 Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57 Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98 Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01 Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30 Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40 mg/0.8 mL (NDC 00074-4339-07) 28 day supply, Rx Only, Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc Vitalab Pharmacy, Inc Class II Terminated 20180516
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc. Vitalab Pharmacy, Inc Class II Terminated 20180516
Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc Vitalab Pharmacy, Inc Class II Terminated 20180516
Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc Vitalab Pharmacy, Inc Class II Terminated 20180516
Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc Vitalab Pharmacy, Inc Class II Terminated 20180516
Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc Vitalab Pharmacy, Inc Class II Terminated 20180516
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01 Dr. Reddy's Laboratories, Inc. Class II Terminated 20180516
Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01 Sanofi-Aventis U.S. LLC Class II Terminated 20180509
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45 Rhodes Pharmaceuticals, L.P. Class III Terminated 20180509
Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52 AuroMedics Pharma LLC Class II Terminated 20180509
Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-47 AuroMedics Pharma LLC Class II Terminated 20180509
Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47. AuroMedics Pharma LLC Class II Terminated 20180509
Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47. AuroMedics Pharma LLC Class II Terminated 20180509
Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47. AuroMedics Pharma LLC Class II Terminated 20180509
Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for: AuroMedics Pharma, LLC, NDC 55150-243-46. AuroMedics Pharma LLC Class II Terminated 20180509
Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51 AuroMedics Pharma LLC Class II Terminated 20180509
PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 Coastal Meds, LLC. Class II Terminated 20180502
METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 Coastal Meds, LLC. Class II Terminated 20180502
LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 Coastal Meds, LLC. Class II Terminated 20180502
LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 Coastal Meds, LLC. Class II Terminated 20180502
LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 Coastal Meds, LLC. Class II Terminated 20180502
LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 Coastal Meds, LLC. Class II Terminated 20180502
LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 Coastal Meds, LLC. Class II Terminated 20180502
HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 Coastal Meds, LLC. Class II Terminated 20180502
ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 Coastal Meds, LLC. Class II Terminated 20180502
CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 Coastal Meds, LLC. Class II Terminated 20180502
Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10 Mckesson Packaging Services Class III Terminated 20180502
Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10 Mckesson Packaging Services Class III Terminated 20180502
Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10 Mckesson Packaging Services Class III Terminated 20180502