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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 · FDAAugust 18, 2025Serious

Amneal Pharmaceuticals, LLC — chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only

Prescription medicine · Amneal Pharmaceuticals, LLC · 7,228 100-count bottles affected

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism.

Food & drug recall · FDAAugust 13, 2025Serious

Sandoz Inc — Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only

Prescription medicine · Sandoz Inc · 1,680 bottles affected

Temperature Abuse

Food & drug recall · FDAAugust 12, 2025Serious

VIONA PHARMACEUTICALS INC — Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only

Prescription medicine · VIONA PHARMACEUTICALS INC · 3960 bottles affected

Discoloration

Food & drug recall · FDAAugust 11, 2025Serious

Lannett Company Inc. — Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only

Prescription medicine · Lannett Company Inc. · 8544 bottles affected

Labeling: Label Mix-up.

Food & drug recall · FDAAugust 8, 2025Serious

Glenmark Pharmaceuticals Inc., USA — Theophylline extended-release tablets 400mg, 100-count bottle, Rx only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 22,656 bottles affected

Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the…

Food & drug recall · FDAAugust 8, 2025Serious

Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only

Prescription medicine · Breckenridge Pharmaceutical, Inc. · 3,591 bottles affected

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

Food & drug recall · FDAAugust 7, 2025Serious

Glenmark Pharmaceuticals Inc., USA — Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 6,432 bottles affected

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Food & drug recall · FDAAugust 7, 2025Serious

Glenmark Pharmaceuticals Inc., USA — Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 44,328 bottles affected

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Food & drug recall · FDAAugust 7, 2025Serious

Glenmark Pharmaceuticals Inc., USA — Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 4,800 bottles affected

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Food & drug recall · FDAAugust 6, 2025Serious

Westminster Pharmaceuticals LLC — Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only

Prescription medicine · Westminster Pharmaceuticals LLC · 16,672 1000-count bottles affected

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Food & drug recall · FDAAugust 6, 2025Serious

Glenmark Pharmaceuticals Inc., USA — Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 14,976 bottles affected

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Food & drug recall · FDAAugust 6, 2025Serious

Westminster Pharmaceuticals LLC — Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only

Prescription medicine · Westminster Pharmaceuticals LLC · 4,456 1000-count bottles affected

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Food & drug recall · FDAAugust 6, 2025Serious

Glenmark Pharmaceuticals Inc., USA — Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 17, 496 bottles affected

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Food & drug recall · FDAAugust 5, 2025Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 11,328 bottles affected

Presence of foreign substance: identified as aluminum.

Food & drug recall · FDAAugust 5, 2025Serious

Cardinal Health Inc. — Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer package - NDC 55154-35

Prescription medicine · Cardinal Health Inc. · 10 bags affected

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

Food & drug recall · FDAAugust 4, 2025Serious

PFIZER INC — Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only

Prescription medicine · PFIZER INC · 49,620 vials affected

Lack of Assurance of Sterility.

Food & drug recall · FDAAugust 4, 2025Serious

B BRAUN MEDICAL INC — Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.

Prescription medicine · B BRAUN MEDICAL INC · 74,088 containers affected

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Food & drug recall · FDAAugust 4, 2025Serious

B BRAUN MEDICAL INC — 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.

Prescription medicine · B BRAUN MEDICAL INC · 23,100 containers affected

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Food & drug recall · FDAAugust 4, 2025Serious

PFIZER INC — Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.

Prescription medicine · PFIZER INC · 15,750 vials affected

Lack of Assurance of Sterility.

Food & drug recall · FDAJuly 30, 2025Serious

GenoGenix LLC — Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

Prescription medicine · GenoGenix LLC

Lack of Assurance of Sterility

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