November 5, 2025DrugsFDA
Heritage Pharmaceuticals Inc recalls Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Priv
Hazard: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
November 5, 2025DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194
Hazard: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
November 5, 2025DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194
Hazard: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
November 5, 2025DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194
Hazard: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
November 5, 2025DrugsFDA
Amerisource Health Services LLC recalls Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packagin
Hazard: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
November 5, 2025DrugsFDA
Amerisource Health Services LLC recalls Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packa
Hazard: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
November 5, 2025DrugsFDA
Amerisource Health Services LLC recalls Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packa
Hazard: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
November 5, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 519
Hazard: CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
November 5, 2025DrugsFDA
Samsung Bioepis Co., Ltd. recalls HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for
Hazard: Lack of Assurance of Sterility.
October 29, 2025DrugsFDA
ibspot recalls Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou ko
Hazard: Marketed Without an Approved NDA/ANDA
October 29, 2025DrugsFDA
Bristol-Myers Squibb Company recalls Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only,
Hazard: Lack of Assurance of Sterility.
October 29, 2025DrugsFDA
Lannett Company Inc. recalls Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., P
Hazard: Failed Dissolution Specifications
October 29, 2025DrugsFDA
Church & Dwight Co., Inc. recalls ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ
Hazard: Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
October 29, 2025DrugsFDA
Graviti Pharmaceuticals Private Limited recalls Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceu
Hazard: Failed Tablet/Capsule Specifications
October 29, 2025DrugsFDA
Aspiro Pharma Limited recalls Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only
Hazard: Presence of Particulate Matter: Particulate matter identified as glass
October 29, 2025DrugsFDA
Medline Industries, LP recalls Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per c
Hazard: Subpotent Drug
October 29, 2025DrugsFDA
USV Private Limited recalls Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICA
Hazard: Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
October 29, 2025DrugsFDA
JB Chemicals and Pharmaceuticals Ltd recalls Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. o
Hazard: Tablet/Capsules Imprinted with Wrong ID
October 29, 2025DrugsFDA
JB Chemicals and Pharmaceuticals Ltd recalls Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. o
Hazard: Tablet/Capsules Imprinted with Wrong ID
October 29, 2025DrugsFDA
The Harvard Drug Group LLC recalls Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmac
Hazard: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
October 29, 2025DrugsFDA
The Harvard Drug Group LLC recalls Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Phar
Hazard: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
October 22, 2025DrugsFDA
Rising Pharma Holding, Inc. recalls Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma
Hazard: Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
October 22, 2025DrugsFDA
ASTRAZENECA PHARMACEUTICALS recalls Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB
Hazard: Lack of Assurance of Sterility:
October 22, 2025DrugsFDA
Amerisource Health Services LLC recalls Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio
Hazard: CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
October 22, 2025DrugsFDA
Endo USA, Inc. recalls Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by
Hazard: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
October 22, 2025DrugsFDA
STAQ Pharma, Inc. recalls FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42n
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date
October 22, 2025DrugsFDA
STAQ Pharma, Inc. recalls Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, De
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date
October 22, 2025DrugsFDA
STAQ Pharma, Inc. recalls Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date
October 22, 2025DrugsFDA
SV Labs Prescott Corporation recalls Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 11
Hazard: cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
October 22, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blister
Hazard: Failed Impurities/Degradation Specifications