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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

1,993 recalls · newest first

Food & drug recall · FDAJanuary 10, 2025Serious

Teva Pharmaceuticals USA, Inc — Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15

Prescription medicine · Teva Pharmaceuticals USA, Inc · 34,636 cartons affected

Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

Food & drug recall · FDAJanuary 7, 2025Labelling issue

PAI Holdings, LLC. dba Pharmaceutical Associates Inc — Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16

Prescription medicine · PAI Holdings, LLC. dba Pharmaceutical… · 4080 Bottles affected

Superpotent; sodium benzoate preservative

Food & drug recall · FDAJanuary 7, 2025Serious

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 · 4640 units affected

Presence of Foreign Tablets/Capsules

Food & drug recall · FDADecember 30, 2024Serious

Rising Pharma Holding, Inc. — Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only

Prescription medicine · Rising Pharma Holding, Inc. · 42,527 bottles affected

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Food & drug recall · FDADecember 30, 2024Serious

Rising Pharma Holding, Inc. — Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only

Prescription medicine · Rising Pharma Holding, Inc. · 73,680 bottles affected

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Food & drug recall · FDADecember 30, 2024Serious

Granules Pharmaceuticals Inc. — Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only

Prescription medicine · Granules Pharmaceuticals Inc. · 6,804 bottles affected

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

Food & drug recall · FDADecember 30, 2024Serious

Rising Pharma Holding, Inc. — Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles

Prescription medicine · Rising Pharma Holding, Inc. · 244,460 bottles affected

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Food & drug recall · FDADecember 27, 2024Serious

Eugia US LLC — Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10

Prescription medicine · Eugia US LLC · 17,300 10-mL vials affected

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

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 23, 2024Serious

Viatris Inc — Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only

Prescription medicine · Viatris Inc · 6,605/30 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, 2024Highest risk

Astellas Pharma US Inc. — Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan

Prescription medicine · Astellas Pharma US Inc. · 3,500 30-count bottles affected

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Food & drug recall · FDADecember 23, 2024Highest risk

Astellas Pharma US Inc. — Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan

Prescription medicine · Astellas Pharma US Inc. · 14,340 100-count bottles affected

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

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 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, 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 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 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 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

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