FDA Drug Safety
U.S. Food and Drug Administration — Drug recalls and safety communications
17,379 recalls · Page 12 of 348
Moderate Apr 30, 2025
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
Pharmadel, LLC
Low Apr 30, 2025
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701,…
OurPharma LLC
Moderate Apr 30, 2025
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 1379…
Denver Solutions, LLC DBA Leiters Health
Moderate Apr 30, 2025
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United…
Lupin Pharmaceuticals Inc.
Moderate Apr 30, 2025
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
Denver Solutions, LLC DBA Leiters Health
Moderate Apr 30, 2025
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
Denver Solutions, LLC DBA Leiters Health
Moderate Apr 30, 2025
Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, …
Apipharma
Moderate Apr 30, 2025
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englew…
Denver Solutions, LLC DBA Leiters Health
Moderate Apr 30, 2025
Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99
Pharmadel, LLC
Moderate Apr 30, 2025
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
RemedyRepack Inc.
Moderate Apr 23, 2025
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
Direct Rx
Moderate Apr 23, 2025
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured …
Eugia US LLC
Critical Apr 23, 2025
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - …
Dr. Reddy's Laboratories, Inc.
Moderate Apr 23, 2025
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409…
Chattem Inc
Moderate Apr 23, 2025
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuti…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Moderate Apr 16, 2025
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured …
Somerset Therapeutics Private Limited
Moderate Apr 16, 2025
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 726…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of…
ASEGUA THERAPEUTICS LLC
Moderate Apr 16, 2025
Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh …
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Indi…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, I…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775,…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmar…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Prades…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by…
Zydus Pharmaceuticals (USA) Inc
Moderate Apr 16, 2025
Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmar…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Man…
Glenmark Pharmaceuticals Inc., USA
Low Apr 16, 2025
Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by…
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate Apr 16, 2025
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc.,…
Zydus Pharmaceuticals (USA) Inc
Moderate Apr 16, 2025
Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 4547…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceut…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manuf…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Mad…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manu…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 4547…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceutic…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 45477…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distribute…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Man…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 0…
Somerset Therapeutics Private Limited
Moderate Apr 16, 2025
Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Li…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Indi…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b) 0.33 OZ (9.45g), UPC 8 42944…
Alchemee, LLC
Moderate Apr 16, 2025
Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 7006…
Somerset Therapeutics Private Limited
Moderate Apr 16, 2025
Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manu…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampu…
Glenmark Pharmaceuticals Inc., USA
Moderate Apr 16, 2025
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, …
B. Braun Medical Inc