Drugs Recalls
17,415 recalls in this category
FDA Drug
Class II
Ongoing
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, R
June 2, 2025
Tailstorm Health INC
14,725 vials units
FDA Drug
Class II
Ongoing
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contai
June 2, 2025
Tailstorm Health INC
975 vials units
FDA Drug
Class II
Ongoing
LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Onl
June 2, 2025
Tailstorm Health INC
29,700 vials units
FDA Drug
Class I
Ongoing
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceutica
June 2, 2025
Amneal Pharmaceuticals LLC
6396 bottles units
FDA Drug
Class II
Ongoing
LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant
June 2, 2025
Tailstorm Health INC
4875 vials units
FDA Drug
Class II
Ongoing
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, N
May 30, 2025
Zydus Pharmaceuticals USA Inc
11,616 bottles units
FDA Drug
Class II
Ongoing
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South C
May 30, 2025
Advanced Pharmaceutical Technology, Inc.
26 vials units
FDA Drug
Class III
Ongoing
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Val
May 29, 2025
Macleods Pharmaceuticals Ltd
1,344- 1000 count bottles units
FDA Drug
Class II
Ongoing
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-
May 29, 2025
Eugia US LLC
48,000 vials units
FDA Drug
Class II
Ongoing
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2
May 28, 2025
Apotex Corp.
87,840 bottles units
FDA Drug
Class II
Ongoing
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4
May 28, 2025
Apotex Corp.
105,456 Bottles units
FDA Drug
Class II
Ongoing
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Fores
May 28, 2025
Pfizer Inc.
98,410 vials units
FDA Drug
Class II
Ongoing
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4
May 28, 2025
Apotex Corp.
20,648 bottles units
FDA Drug
Class II
Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, F
May 28, 2025
Apotex Corp.
6,288 Bottles units
FDA Drug
Class II
Ongoing
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
May 27, 2025
Fresenius Medical Care Holdings, Inc.
3,651,468 containers units
FDA Drug
Class II
Ongoing
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC
May 27, 2025
Torrent Pharma Inc
972 Cartons units
FDA Drug
Class II
Ongoing
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 136
May 27, 2025
Torrent Pharma Inc
3672 Bottles units
FDA Drug
Class II
Ongoing
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2
May 23, 2025
Teva Pharmaceuticals USA, Inc.
36612 cartons units
FDA Drug
Class II
Ongoing
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC
May 23, 2025
Ascend Laboratories LLC
10,620 - 200 mL bottles units
FDA Drug
Class II
Ongoing
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8
May 23, 2025
Consumer Product Partners, LLC
125,040 bottles units
FDA Drug
Class II
Ongoing
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC
May 23, 2025
Ascend Laboratories LLC
48,936 - 100 mL bottles units
FDA Drug
Class II
Ongoing
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
May 22, 2025
Aurobindo Pharma USA Inc
4,608 bottles units
FDA Drug
Class II
Ongoing
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
16 syringes units
FDA Drug
Class II
Ongoing
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
826 syringes units
FDA Drug
Class II
Ongoing
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
164 syringes units
FDA Drug
Class II
Ongoing
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
4 syringes units
FDA Drug
Class I
Completed
UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295
May 21, 2025
Umary-USA.com
1,342 30-count bottles units
FDA Drug
Class II
Ongoing
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
216 syringes units
FDA Drug
Class II
Ongoing
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
5 units
FDA Drug
Class II
Ongoing
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
16 syringes units
FDA Drug
Class II
Ongoing
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
24 syringes units
FDA Drug
Class II
Ongoing
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
242 syringes units
FDA Drug
Class II
Ongoing
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
32 syringes units
FDA Drug
Class II
Ongoing
CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
60 syringes units
FDA Drug
Class I
Completed
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
May 21, 2025
Umary-USA.com
1,704 30-count bottles units
FDA Drug
Class II
Ongoing
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, a
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
102 syringes units
FDA Drug
Class II
Ongoing
LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, S
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
64 syringes units
FDA Drug
Class II
Ongoing
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
28 syringes units
FDA Drug
Class III
Ongoing
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Gl
May 19, 2025
Glenmark Pharmaceuticals Inc., USA
6,759 Con - 90 bottle pack units
FDA Drug
Class II
Ongoing
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flam
May 15, 2025
Carefusion 213, Llc
385,200 applicators units
FDA Drug
Class II
Ongoing
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton),
May 15, 2025
Amerisource Health Services LLC
21 cartons units
FDA Drug
Class II
Ongoing
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Gl
May 15, 2025
Glenmark Pharmaceuticals Inc., USA
8,520 100-count bottles units
FDA Drug
Class II
Ongoing
Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, M
May 14, 2025
AsttraZeneca Pharmaceuticals LP
a) 807,837 canisters; b) 235,698 canisters units
FDA Drug
Class II
Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Ph
May 13, 2025
Zydus Pharmaceuticals USA Inc
22,152 30 sachets/carton units
FDA Drug
Class II
Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Ph
May 13, 2025
Zydus Pharmaceuticals USA Inc
30,674 30 sachets/carton units
FDA Drug
Class II
Ongoing
Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
May 13, 2025
AvKARE
3,817 50-count cartons units
FDA Drug
Class II
Ongoing
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15
May 9, 2025
AvKARE
962 cartons units
FDA Drug
Class II
Ongoing
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.
May 9, 2025
KVK-Tech, Inc.
9107 bottles units
FDA Drug
Class II
Ongoing
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceutical
May 9, 2025
Alembic Pharmaceuticals Limited
2,946 500-count bottles units
FDA Drug
Class II
Ongoing
Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.
May 9, 2025
KVK-Tech, Inc.
9680 bottles units