Drug and pharmaceutical recalls
17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IILEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIMagnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IICalcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-10-27FDA-DrugLupin Pharmaceuticals Inc.Class IIImipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
- 2021-10-27FDA-DrugDr. Reddy's Laboratories, Inc.Class IIOmeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
- 2021-10-27FDA-DrugTeva Pharmaceuticals USAClass IIAirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- 2021-10-27FDA-DrugTeva Pharmaceuticals USAClass IIAirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- 2021-10-27FDA-DrugTeva Pharmaceuticals USAClass IIAirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- 2021-10-27FDA-DrugTeva Pharmaceuticals USAClass IIAirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- 2021-10-27FDA-DrugTeva Pharmaceuticals USAClass IIAirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- 2021-10-27FDA-DrugAmerican Health PackagingClass IIGlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)
Failed Dissolution Specifications: results were above specification.
- 2021-10-27FDA-DrugPiramal Critical Care, Inc.Class IIRocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
- 2021-10-27FDA-DrugSanitor CorporationClass IICleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3
CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
- 2021-10-27FDA-DrugBeiersdorf IncClass IICoppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
cGMP Deviations
- 2021-10-27FDA-DrugBeiersdorf IncClass IICoppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
cGMP Deviations
- 2021-10-27FDA-DrugBeiersdorf IncClass IICoppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0
cGMP Deviations
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9
Chemical contamination; presence of benzene
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02870 1
Chemical contamination; presence of benzene
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
Chemical contamination; presence of benzene
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
Chemical contamination; presence of benzene
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0
Chemical contamination; presence of benzene
- 2021-10-20FDA-DrugEli Lilly & CompanyClass IGlucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
- 2021-10-20FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass IIPotassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1
Lack of Assurance of Sterility
- 2021-10-20FDA-DrugStrides Pharma Inc.Class IIPotassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.
Failed Dissolution Specifications
- 2021-10-13FDA-DrugRISING PHARMACEUTICALSClass IIMeclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
Labeling: Incorrect Instructions
- 2021-10-13FDA-DrugAkorn, Inc.Class IIBetaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
- 2021-10-13FDA-DrugAzurity Pharmaceuticals, Inc.Class IFirvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05.
Product Mix-up: Incorrect diluent component included in the kit.
- 2021-10-13FDA-DrugAMIVAS (US), LLCClass IIArtesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-10), Rx only, Mfg for: Amivas, LLC, 1209 Orange St., Wilmington, Delaware 19801.
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
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