FDA Drug Safety
U.S. Food and Drug Administration — Drug recalls and safety communications
17,379 recalls · Page 16 of 348
Low Jan 8, 2025
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, …
AvKARE
Moderate Jan 8, 2025
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ…
VIONA PHARMACEUTICALS INC
Moderate Jan 8, 2025
Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 5…
AvKARE
Moderate Jan 8, 2025
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Lupin Pharmaceuticals Inc.
Moderate Jan 8, 2025
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ…
Hikma Injectables USA Inc
Critical Jan 8, 2025
FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles
GNMart LLC
Moderate Jan 8, 2025
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 630…
Hikma Injectables USA Inc
Low Jan 8, 2025
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-…
SOMERSET THERAPEUTICS LLC
Moderate Jan 8, 2025
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, N…
VIONA PHARMACEUTICALS INC
Low Jan 8, 2025
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, ww…
AvKARE
Moderate Jan 1, 2025
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (…
Breckenridge Pharmaceutical, Inc
Moderate Jan 1, 2025
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, ND…
Glenmark Pharmaceuticals Inc., USA
Moderate Jan 1, 2025
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetr…
Curium US, LLC
Moderate Jan 1, 2025
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For …
Amerisource Health Services LLC
Moderate Jan 1, 2025
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For B…
Amerisource Health Services LLC
Moderate Jan 1, 2025
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source N…
RemedyRepack Inc.
Moderate Jan 1, 2025
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For B…
Amerisource Health Services LLC
Moderate Jan 1, 2025
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, N…
Glenmark Pharmaceuticals Inc., USA
Moderate Jan 1, 2025
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
PD-Rx Pharmaceuticals, Inc.
Moderate Jan 1, 2025
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
MXBBB
Moderate Jan 1, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, …
Breckenridge Pharmaceutical, Inc
Moderate Jan 1, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, F…
Amerisource Health Services LLC
Moderate Dec 25, 2024
Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027…
Keystone Industries
Moderate Dec 25, 2024
Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Profession…
Keystone Industries
Moderate Dec 25, 2024
Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for…
Keystone Industries
Moderate Dec 25, 2024
Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Su…
Provepharm Inc.
Moderate Dec 25, 2024
safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safc…
Keystone Industries
Moderate Dec 25, 2024
Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, den…
Keystone Industries
Moderate Dec 25, 2024
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
Keystone Industries
Moderate Dec 25, 2024
Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th …
Keystone Industries
Moderate Dec 25, 2024
LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processin…
Regenerative Processing Plant, LLC
Moderate Dec 25, 2024
Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply…
Keystone Industries
Moderate Dec 25, 2024
VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp…
Apothecus Pharmaceutical Corp.
Moderate Dec 25, 2024
M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue…
Keystone Industries
Moderate Dec 25, 2024
Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08…
Aurobindo Pharma USA Inc
Moderate Dec 25, 2024
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
Keystone Industries
Moderate Dec 25, 2024
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods…
Macleods Pharmaceuticals Ltd
Moderate Dec 25, 2024
Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.
Keystone Industries
Moderate Dec 25, 2024
Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 …
Keystone Industries
Moderate Dec 25, 2024
PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative …
Regenerative Processing Plant, LLC
Moderate Dec 18, 2024
Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, …
Viatris Inc
Moderate Dec 18, 2024
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, …
Viatris Inc
Moderate Dec 18, 2024
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured …
Mylan Institutional, Inc.
Moderate Dec 18, 2024
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured …
Mylan Institutional, Inc.
Moderate Dec 18, 2024
Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, M…
Viatris Inc
Moderate Dec 18, 2024
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured fo…
Mylan Institutional, Inc.
Moderate Dec 18, 2024
Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured …
Mylan Institutional, Inc.
Moderate Dec 18, 2024
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured …
Mylan Institutional, Inc.
Moderate Dec 18, 2024
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 …
LNK International, Inc.
Moderate Dec 18, 2024
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, …
Viatris Inc