FDA Drug · 2021

FDA Drug recalls in 2021

RecallRadar indexes 1,016 FDA Drug recall notices published in 2021. By classification: 135 Class I, 779 Class II, 102 Class III.

• TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 100 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San An…
  FDA Drug · Class II · 2021-11-17 · Vita Pharmacy
• Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx o…
  FDA Drug · Class II · 2021-11-10 · Lupin Pharmaceuticals
• Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx o…
  FDA Drug · Class II · 2021-11-10 · Lupin Pharmaceuticals
• Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
  FDA Drug · Class II · 2021-11-10 · Lupin Pharmaceuticals
• Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only…
  FDA Drug · Class II · 2021-11-10 · Dr Reddy S Laboratories
• Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) bottles, Rx Only…
  FDA Drug · Class II · 2021-11-10 · Dr Reddy S Laboratories
• Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
  FDA Drug · Class II · 2021-11-10 · Lupin Pharmaceuticals
• Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) bottles, Rx…
  FDA Drug · Class II · 2021-11-10 · Dr Reddy S Laboratories
• Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only
  FDA Drug · Class I · 2021-11-10 · Merck Sharp And Dohme
• Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bot…
  FDA Drug · Class I · 2021-11-10 · Bryant Ranch Prepack
• Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 coun…
  FDA Drug · Class II · 2021-11-10 · Dr Reddy S Laboratories
• Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, S…
  FDA Drug · Class II · 2021-11-10 · Dr Reddy S Laboratories
• Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
  FDA Drug · Class II · 2021-11-10 · Lupin Pharmaceuticals
• SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister…
  FDA Drug · Class III · 2021-11-03 · Sun Pharmaceutical Industries
• TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967,…
  FDA Drug · Class III · 2021-11-03 · Ultra Seal
• Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macl…
  FDA Drug · Class III · 2021-11-03 · Macleods Pharma Usa
• CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packet…
  FDA Drug · Class III · 2021-11-03 · Ultra Seal
• METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Pack…
  FDA Drug · Class III · 2021-11-03 · Ultra Seal
• VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,00…
  FDA Drug · Class III · 2021-11-03 · Ultra Seal
• ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18…
  FDA Drug · Class III · 2021-11-03 · Macleods Pharma Usa
• TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packag…
  FDA Drug · Class III · 2021-11-03 · Ultra Seal
• Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged i…
  FDA Drug · Class III · 2021-11-03 · Ultra Seal
• TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Mac…
  FDA Drug · Class III · 2021-11-03 · Macleods Pharma Usa
• AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case…
  FDA Drug · Class III · 2021-11-03 · Ultra Seal
• Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-…
  FDA Drug · Class III · 2021-11-03 · Lupin Pharmaceuticals
• AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured…
  FDA Drug · Class III · 2021-11-03 · Sun Pharmaceutical Industries
• Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161,…
  FDA Drug · Class III · 2021-11-03 · Ultra Seal
• ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
  FDA Drug · Class II · 2021-11-03 · First Royal Care
• AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC,…
  FDA Drug · Class II · 2021-10-27 · Teva Pharmaceuticals Usa
• GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured b…
  FDA Drug · Class II · 2021-10-27 · American Health Packaging
• Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC…
  FDA Drug · Class I · 2021-10-27 · Beiersdorf
• AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Te…
  FDA Drug · Class II · 2021-10-27 · Teva Pharmaceuticals Usa
• AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC,…
  FDA Drug · Class II · 2021-10-27 · Teva Pharmaceuticals Usa
• Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave S…
  FDA Drug · Class II · 2021-10-27 · Sanitor
• Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC…
  FDA Drug · Class II · 2021-10-27 · Beiersdorf
• Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897…
  FDA Drug · Class I · 2021-10-27 · Beiersdorf
• Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a ca…
  FDA Drug · Class II · 2021-10-27 · Dr Reddy S Laboratories
• Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC…
  FDA Drug · Class I · 2021-10-27 · Beiersdorf
• Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, B…
  FDA Drug · Class I · 2021-10-27 · Beiersdorf
• AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Te…
  FDA Drug · Class II · 2021-10-27 · Teva Pharmaceuticals Usa
• Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc
  FDA Drug · Class II · 2021-10-27 · Lupin Pharmaceuticals
• Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897…
  FDA Drug · Class II · 2021-10-27 · Beiersdorf
• AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Fra…
  FDA Drug · Class II · 2021-10-27 · Teva Pharmaceuticals Usa
• Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Ma…
  FDA Drug · Class II · 2021-10-27 · Piramal Critical Care
• Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897…
  FDA Drug · Class II · 2021-10-27 · Beiersdorf
• Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897…
  FDA Drug · Class I · 2021-10-27 · Beiersdorf
• Potassium 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…
  FDA Drug · Class II · 2021-10-20 · Ssm Health Care St Louis
• Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial
  FDA Drug · Class I · 2021-10-20 · Eli Lilly And
• Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru…
  FDA Drug · Class II · 2021-10-20 · Strides Pharma
• Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile…
  FDA Drug · Class II · 2021-10-13 · Amivas Us
• Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc
  FDA Drug · Class II · 2021-10-13 · Rising Pharmaceuticals
• ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. A…
  FDA Drug · Class I · 2021-10-13 · Alpha Tek
• Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydr…
  FDA Drug · Class I · 2021-10-13 · Azurity Pharmaceuticals
• Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., L…
  FDA Drug · Class II · 2021-10-13 · Akorn
• Occular Allergy Blend 87% Alcohol
  FDA Drug · Class II · 2021-10-06 · Washington Homeopathic Products
• La Core LCL-2-0191 Blend, 149,980ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Only, Liter LCL-2-0191-Bend: 12% Lycopodium Cl…
  FDA Drug · Class II · 2021-10-06 · Washington Homeopathic Products
• Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN…
  FDA Drug · Class II · 2021-10-06 · Monarch Pcm
• Z-103 GU DETOXING. Contents 1000ml 20% Alcohol
  FDA Drug · Class II · 2021-10-06 · Washington Homeopathic Products
• Z-1050 Formula Hepatodetox
  FDA Drug · Class II · 2021-10-06 · Washington Homeopathic Products
• Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50, Avobenzone 2.7%, Homosalate 5%, Octisalate 4.5%, Octocrylene…
  FDA Drug · Class II · 2021-10-06 · Johnson And Johnson Consumer
• Humulus 6X, 15X, Sucrose/Lactose Pills, 6X Packaged as a) 4dr, UPC 7 40640 33969 5
  FDA Drug · Class II · 2021-10-06 · Washington Homeopathic Products

Other years

2026 (565) · 2025 (765) · 2024 (657) · 2023 (1,252) · 2022 (1,349) · 2021 (1,016) · 2020 (1,035) · 2019 (2,152) · 2018 (1,426) · 2017 (1,073) · 2016 (1,254) · 2015 (2,020) · 2014 (1,562) · 2013 (1,377) · 2012 (434)