FDA Drug Safety
U.S. Food and Drug Administration — Drug recalls and safety communications
17,379 recalls · Page 14 of 348
Moderate Mar 19, 2025
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pha…
Chattem Inc
Moderate Mar 19, 2025
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Aspen Biopharma Labs Pvt., Ltd.
Moderate Mar 19, 2025
Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally…
Aspen Biopharma Labs Pvt., Ltd.
Low Mar 19, 2025
Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nag…
Kowa Pharmaceuticals America
Moderate Mar 19, 2025
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St S…
Denison Pharmaceuticals, LLC
Moderate Mar 19, 2025
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS …
Johnson, S C and Son, Inc
Critical Mar 19, 2025
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 09…
ICU Medical, Inc.
Moderate Mar 19, 2025
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain…
Breckenridge Pharmaceutical, Inc.
Moderate Mar 19, 2025
Alprostadil Container Description: Amber color bottle
Aspen Biopharma Labs Pvt., Ltd.
Moderate Mar 19, 2025
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spai…
Breckenridge Pharmaceutical, Inc.
Moderate Mar 19, 2025
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-33…
Nephron Sterile Compounding Center LLC
Moderate Mar 19, 2025
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Aspen Biopharma Labs Pvt., Ltd.
Critical Mar 19, 2025
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd.…
Central Admixture Pharmacy Services, Inc.
Moderate Mar 19, 2025
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spai…
Breckenridge Pharmaceutical, Inc.
Moderate Mar 19, 2025
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL,…
Sigan Industries Group Inc.
Moderate Mar 19, 2025
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Aspen Biopharma Labs Pvt., Ltd.
Critical Mar 19, 2025
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, US…
ICU Medical, Inc.
Moderate Mar 19, 2025
Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and U…
Johnson, S C and Son, Inc
Critical Mar 19, 2025
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation,…
CareFusion 213, LLC
Moderate Mar 19, 2025
Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally pack…
Aspen Biopharma Labs Pvt., Ltd.
Moderate Mar 12, 2025
Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Sa…
Safecor Health, LLC
Moderate Mar 12, 2025
Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Colum…
Safecor Health, LLC
Moderate Mar 12, 2025
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. …
Safecor Health, LLC
Moderate Mar 12, 2025
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Dist…
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate Mar 12, 2025
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-…
Zydus Pharmaceuticals (USA) Inc
Moderate Mar 12, 2025
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 4…
Safecor Health, LLC
Moderate Mar 12, 2025
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 0053613…
Safecor Health, LLC
Moderate Mar 12, 2025
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-…
Zydus Pharmaceuticals (USA) Inc
Moderate Mar 5, 2025
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
Padagis US LLC
Moderate Mar 5, 2025
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was rep…
Turbare Manufacturing
Moderate Mar 5, 2025
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by W…
Wuxi Medical lnstrument Factory Co., Ltd.
Moderate Feb 26, 2025
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-…
Glenmark Pharmaceuticals Inc., USA
Moderate Feb 26, 2025
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Moderate Feb 26, 2025
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-…
Glenmark Pharmaceuticals Inc., USA
Moderate Feb 26, 2025
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Phar…
Glenmark Pharmaceuticals Inc., USA
Moderate Feb 26, 2025
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pha…
Glenmark Pharmaceuticals Inc., USA
Moderate Feb 26, 2025
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-…
Glenmark Pharmaceuticals Inc., USA
Moderate Feb 26, 2025
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, …
Fagron Compounding Services
Moderate Feb 26, 2025
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Phar…
Glenmark Pharmaceuticals Inc., USA
Moderate Feb 26, 2025
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-…
Glenmark Pharmaceuticals Inc., USA
Critical Feb 26, 2025
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook…
Alvogen, Inc
Moderate Feb 26, 2025
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Phar…
Glenmark Pharmaceuticals Inc., USA
Moderate Feb 26, 2025
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, N…
AvKARE
Critical Feb 26, 2025
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc…
Provepharm Inc.
Moderate Feb 26, 2025
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from N…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Moderate Feb 26, 2025
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-…
Glenmark Pharmaceuticals Inc., USA
Moderate Feb 26, 2025
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462…
Glenmark Pharmaceuticals Inc., USA
Moderate Feb 26, 2025
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Phar…
Glenmark Pharmaceuticals Inc., USA
Moderate Feb 26, 2025
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-…
Glenmark Pharmaceuticals Inc., USA
Moderate Feb 26, 2025
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from N…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories