Prescription medicine recalls

Prescription medicine · ibspot · 3 boxes affected

ibspot — Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang xian gong ye yuan qu, X003SR097N

Marketed Without an Approved NDA/ANDA

Prescription medicine · Amerisource Health Services LLC · 27,868 blister packs affected

Amerisource Health Services LLC — Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024.

Prescription medicine · Breckenridge Pharmaceutical, Inc. · 172,263 bottles affected

Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona

CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

Food & drug recall · FDAOctober 9, 2025Labelling issue

STAQ Pharma, Inc. — Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.

Prescription medicine · STAQ Pharma, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date

Food & drug recall · FDAOctober 9, 2025Labelling issue

STAQ Pharma, Inc. — FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.

Prescription medicine · STAQ Pharma, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date

Prescription medicine · USV Private Limited · 8,952 bottles affected

USV Private Limited — Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles

Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.

Food & drug recall · FDAOctober 9, 2025Labelling issue

STAQ Pharma, Inc. — Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.

Prescription medicine · STAQ Pharma, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date

Food & drug recall · FDAOctober 8, 2025Serious

ASTRAZENECA PHARMACEUTICALS — Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only

Prescription medicine · ASTRAZENECA PHARMACEUTICALS · 916 pre-filled syringes affected

Lack of Assurance of Sterility:

Prescription medicine · Teva Pharmaceuticals USA, Inc · 291,512 bottles affected

Teva Pharmaceuticals USA, Inc — Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable…

Prescription medicine · Rising Pharma Holding, Inc. · 2,064 100-count bottles affected

Rising Pharma Holding, Inc. — Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only

Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150…

Prescription medicine · Teva Pharmaceuticals USA, Inc · 181,659 bottles affected

Teva Pharmaceuticals USA, Inc — Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable…

Prescription medicine · Teva Pharmaceuticals USA, Inc · 107,673 affected

Teva Pharmaceuticals USA, Inc — Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable…

Prescription medicine · Heritage Pharmaceuticals Inc · 5,882 bottles. affected

Heritage Pharmaceuticals Inc — Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Prescription medicine · Heritage Pharmaceuticals Inc · 2,418 bottles. affected

Heritage Pharmaceuticals Inc — Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Prescription medicine · VIONA PHARMACEUTICALS INC · 13080 bottles affected

VIONA PHARMACEUTICALS INC — Tavaborole Topical solution 5%, 10 mL bottle, Rx only

Discoloration

Prescription medicine · Heritage Pharmaceuticals Inc · 8,754 bottles. affected

Heritage Pharmaceuticals Inc — Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Prescription medicine · Heritage Pharmaceuticals Inc · 5880 bottles. affected

Heritage Pharmaceuticals Inc — Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Prescription medicine · Heritage Pharmaceuticals Inc · 6,979 bottles. affected

Heritage Pharmaceuticals Inc — Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.