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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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Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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

2,102 recalls · newest first

Food & drug recall · FDADecember 23, 2024Serious

Viatris Inc — Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only

Prescription medicine · Viatris Inc · 1,215/30 count bottles affected

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

Food & drug recall · FDADecember 23, 2024Serious

First Aid Beauty Ltd — First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6

Prescription medicine · First Aid Beauty Ltd · 2756 jars affected

CGMP Deviations; product intended for quarantine was inadvertently distributed

Food & drug recall · FDADecember 20, 2024Highest risk

ENDO USA, Inc. — Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials

Prescription medicine · ENDO USA, Inc. · 44,397 amber glass vials affected

Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)

Food & drug recall · FDADecember 20, 2024Serious

Lupin Pharmaceuticals Inc. — Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only

Prescription medicine · Lupin Pharmaceuticals Inc. · 480 1000-count bottles affected

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term…

Food & drug recall · FDADecember 19, 2024Serious

Hikma Injectables USA Inc — phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

Prescription medicine · Hikma Injectables USA Inc

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Food & drug recall · FDADecember 19, 2024Serious

Hikma Injectables USA Inc — ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. ND

Prescription medicine · Hikma Injectables USA Inc · 1,800 syringes affected

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Food & drug recall · FDADecember 19, 2024Labelling issue

West-Ward Columbus Inc — Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only

Prescription medicine · West-Ward Columbus Inc · 2591 100-count boxes affected

Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.

Food & drug recall · FDADecember 18, 2024Serious

Eugia US LLC — medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension

Prescription medicine · Eugia US LLC · 19872 vials affected

CGMP Deviations

Food & drug recall · FDADecember 18, 2024Serious

Granules Pharmaceuticals Inc. — Colchicine Capsules 0.6 mg, 30-count bottles, Rx only

Prescription medicine · Granules Pharmaceuticals Inc. · 96 Bottles affected

Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.

Food & drug recall · FDADecember 17, 2024Serious

Amerisource Health Services LLC — glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only

Prescription medicine · Amerisource Health Services LLC · 2,028 units (cartons of 30 individual unit doses) affected

Failed Dissolution Specifications:

Food & drug recall · FDADecember 16, 2024Labelling issue

SOMERSET THERAPEUTICS LLC — Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only

Prescription medicine · SOMERSET THERAPEUTICS LLC · 5,870 bottles affected

Failed Impurities/Degradation Specifications

Food & drug recall · FDADecember 16, 2024Serious

FDC Limited — Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only

Prescription medicine · FDC Limited · 136,181 bottles affected

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Food & drug recall · FDADecember 13, 2024Serious

Amerisource Health Services LLC — Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC

Prescription medicine · Amerisource Health Services LLC · 5,178 cartons affected

Presence of Foreign Tablets/Capsules

Food & drug recall · FDADecember 12, 2024Highest risk

GNMart LLC — FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles

Prescription medicine · GNMart LLC · 374 bottles affected

Marketed without an approved NDA/ANDA.

Food & drug recall · FDADecember 12, 2024Labelling issue

Akron Pharma, Inc. — Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma

Prescription medicine · Akron Pharma, Inc. · 456 bottles affected

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Food & drug recall · FDADecember 12, 2024Serious

Ascend Laboratories, LLC — Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only

Prescription medicine · Ascend Laboratories, LLC · 1971 bottles affected

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

Food & drug recall · FDADecember 12, 2024Labelling issue

Akron Pharma, Inc. — Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma

Prescription medicine · Akron Pharma, Inc. · 324 bottles affected

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Food & drug recall · FDADecember 12, 2024Labelling issue

Akron Pharma, Inc. — Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma

Prescription medicine · Akron Pharma, Inc. · 7198 bottles affected

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Food & drug recall · FDADecember 12, 2024Serious

Ascend Laboratories, LLC — Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only

Prescription medicine · Ascend Laboratories, LLC · 10,444 bottles affected

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

Food & drug recall · FDADecember 11, 2024Serious

Glenmark Pharmaceuticals Inc., USA — chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

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