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The Recall Registry is not a government service and does not issue recalls. We gather published recall notices from the U.S. Consumer Product Safety Commission, the U.S. Food and Drug Administration and the National Highway Traffic Safety Administration, and rewrite them in plain language. Always confirm the details with the issuing agency using the link on each recall page.

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Home › All recalls › Prescription medicine

Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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Prescription medicine1,991 Over-the-counter & supplements377 Mobility & home health182

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Highest riskSeriousWorth checkingLabelling issueTap any recall for the hazard and what to do

1,991 recalls · newest first

Food & drug recall · FDASeptember 12, 2025Serious

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapoli

Prescription medicine · The Harvard Drug Group LLC dba Major… · 2064 blister packs affected

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Food & drug recall · FDASeptember 12, 2025Labelling issue

Letco Medical LLC — Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604

Prescription medicine · Letco Medical LLC · 173 500 ml bottles affected

Labeling: Not Elsewhere Classified

Food & drug recall · FDASeptember 12, 2025Labelling issue

JB Chemicals and Pharmaceuticals Ltd — Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles

Prescription medicine · JB Chemicals and Pharmaceuticals Ltd · 9936 bottles affected

Tablet/Capsules Imprinted with Wrong ID

Food & drug recall · FDASeptember 5, 2025Serious

Sandoz Inc — Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial

Prescription medicine · Sandoz Inc · 6 vials affected

cGMP deviations: Temperature excursion during transportation.

Food & drug recall · FDASeptember 5, 2025Serious

Apotex Corp. — Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile

Prescription medicine · Apotex Corp. · 151,034 bottles affected

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Food & drug recall · FDASeptember 5, 2025Serious

Apotex Corp. — Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile

Prescription medicine · Apotex Corp. · 493,468 bottles affected

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Food & drug recall · FDASeptember 5, 2025Labelling issue

Endo USA, Inc. — Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only

Prescription medicine · Endo USA, Inc. · 1,041 cartons affected

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Food & drug recall · FDASeptember 4, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · 4344 bottles affected

Failed Impurity/Degradation Specifications

Food & drug recall · FDASeptember 4, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · 4440 bottles affected

Failed Impurity/Degradation Specifications

Food & drug recall · FDASeptember 3, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · N/A affected

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Food & drug recall · FDASeptember 3, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · N/A affected

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Food & drug recall · FDASeptember 3, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · N/A affected

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Food & drug recall · FDASeptember 3, 2025Serious

Glenmark Pharmaceuticals Inc., USA — Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 26,928 packs affected

Failed Impurities/Degradation Specifications

Food & drug recall · FDASeptember 3, 2025Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 1870 kits affected

Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of…

Food & drug recall · FDASeptember 3, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · N/A affected

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Food & drug recall · FDASeptember 3, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · N/A affected

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Food & drug recall · FDASeptember 3, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · N/A affected

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Food & drug recall · FDASeptember 3, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · N/A affected

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Food & drug recall · FDASeptember 3, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · N/A affected

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Food & drug recall · FDASeptember 3, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · N/A affected

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

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