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Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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1,991 recalls · newest first

Food & drug recall · FDAJune 25, 2026Serious

Bell Pharmaceuticals, Inc — LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.

Prescription medicine · Bell Pharmaceuticals, Inc · 5, 471 units affected

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Food & drug recall · FDAJune 25, 2026Serious

Bell Pharmaceuticals, Inc — meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.

Prescription medicine · Bell Pharmaceuticals, Inc · 993 units affected

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Food & drug recall · FDAJune 25, 2026Serious

Bell Pharmaceuticals, Inc — FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01)

Prescription medicine · Bell Pharmaceuticals, Inc · 11, 977 units affected

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Food & drug recall · FDAJune 25, 2026Serious

Bell Pharmaceuticals, Inc — Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Plea

Prescription medicine · Bell Pharmaceuticals, Inc · 29, 474 units affected

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Food & drug recall · FDAJune 25, 2026Serious

Bell Pharmaceuticals, Inc — TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34)

Prescription medicine · Bell Pharmaceuticals, Inc · 16,156 units affected

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Food & drug recall · FDAJune 24, 2026Highest risk

JB Chemicals and Pharmaceuticals Ltd — Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle

Prescription medicine · JB Chemicals and Pharmaceuticals Ltd · 34,020 100-count bottles. affected

Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride…

Food & drug recall · FDAJune 24, 2026Serious

QuVa Pharma, Inc. — Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.

Prescription medicine · QuVa Pharma, Inc. · N/A affected

Failed Impurities/Degradation Specifications

Food & drug recall · FDAJune 24, 2026Serious

Reliance Life Sciences Private Limited — Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only

Prescription medicine · Reliance Life Sciences Private Limited · 12,000 vials affected

Lack of Sterility Assurance

Food & drug recall · FDAJune 24, 2026Serious

Reliance Life Sciences Private Limited — Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only

Prescription medicine · Reliance Life Sciences Private Limited · 8,001 vials affected

Lack of Sterility Assurance

Food & drug recall · FDAJune 24, 2026Serious

Reliance Life Sciences Private Limited — Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use

Prescription medicine · Reliance Life Sciences Private Limited · 11,400 vials affected

Lack of Sterility Assurance

Food & drug recall · FDAJune 24, 2026Serious

Reliance Life Sciences Private Limited — Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only

Prescription medicine · Reliance Life Sciences Private Limited · 5,020 vials affected

Lack of Sterility Assurance

Food & drug recall · FDAJune 23, 2026Serious

Padagis US LLC — Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube

Prescription medicine · Padagis US LLC · 180,936 tubes affected

Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

Food & drug recall · FDAJune 23, 2026Serious

Lupin Pharmaceuticals Inc. — Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only

Prescription medicine · Lupin Pharmaceuticals Inc. · 64,894 units affected

CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

Food & drug recall · FDAJune 22, 2026Serious

Direct Rx — DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

Prescription medicine · Direct Rx · 263 Bottles affected

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Food & drug recall · FDAJune 17, 2026Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 3,456 30-count bottles affected

Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

Food & drug recall · FDAJune 16, 2026Serious

The Harvard Drug Group LLC — Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Meth

Prescription medicine · The Harvard Drug Group LLC · 790 Cartons. affected

Subpotent Drug

Food & drug recall · FDAJune 12, 2026Serious

Par Health USA, LLC — Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use

Prescription medicine · Par Health USA, LLC · 46,334 units affected

Crystallization; identified as Buprenorphine free base

Food & drug recall · FDAJune 12, 2026Serious

Boehringer Ingelheim Pharmaceuticals, Inc. — Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only

Prescription medicine · Boehringer Ingelheim Pharmaceuticals, Inc. · 560 bottles affected

CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been…

Food & drug recall · FDAJune 11, 2026Serious

CareFusion 213, LLC — BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 5436

Prescription medicine · CareFusion 213, LLC · 18,000 units affected

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…

Food & drug recall · FDAJune 11, 2026Serious

BioMed Laboratories, LLC. — Medline Remedy Specialized Silicone Cream (Hydraguard-D )

Prescription medicine · BioMed Laboratories, LLC. · 509,652 tubes affected

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.