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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

2,003 recalls · newest first

Food & drug recall · FDANovember 1, 2023Serious

Apotex Corp. — Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9

Prescription medicine · Apotex Corp. · 4,074 affected

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Food & drug recall · FDANovember 1, 2023Serious

Padagis US LLC — Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only

Prescription medicine · Padagis US LLC · 7,032 bottles affected

Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

Food & drug recall · FDANovember 1, 2023Serious

Apotex Corp. — Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9

Prescription medicine · Apotex Corp. · 48,623 affected

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Food & drug recall · FDANovember 1, 2023Serious

Apotex Corp. — Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4

Prescription medicine · Apotex Corp. · 34,392 affected

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Food & drug recall · FDANovember 1, 2023Serious

Apotex Corp. — Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4

Prescription medicine · Apotex Corp. · 25,776 affected

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Food & drug recall · FDAOctober 31, 2023Highest risk

Cardinal Health Inc. — LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile

Prescription medicine · Cardinal Health Inc. · 21,802 bottles affected

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Food & drug recall · FDAOctober 31, 2023Highest risk

Cardinal Health Inc. — LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile

Prescription medicine · Cardinal Health Inc. · 11629 units affected

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Food & drug recall · FDAOctober 31, 2023Highest risk

Cardinal Health Inc. — LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile

Prescription medicine · Cardinal Health Inc. · 11,782 bottles affected

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Food & drug recall · FDAOctober 30, 2023Labelling issue

Grato Holdings, Inc. — V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle

Prescription medicine · Grato Holdings, Inc. · 1,333 30mL bottles affected

Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated…

Food & drug recall · FDAOctober 27, 2023Labelling issue

NCS Healthcare of Kentucky Inc — Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgo

Prescription medicine · NCS Healthcare of Kentucky Inc · 1,344 cards affected

Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots

Food & drug recall · FDAOctober 27, 2023Labelling issue

NCS Healthcare of Kentucky Inc — Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.

Prescription medicine · NCS Healthcare of Kentucky Inc · 12 cards affected

Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots

Food & drug recall · FDAOctober 27, 2023Serious

Amneal Pharmaceuticals of New York, LLC — Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle

Prescription medicine · Amneal Pharmaceuticals of New York, LLC · 9,263 100-count bottles affected

Failed Dissolution Specifications

Food & drug recall · FDAOctober 26, 2023Labelling issue

VistaPharm LLC — Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle

Prescription medicine · VistaPharm LLC · 11,633 bottles affected

Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.

Food & drug recall · FDAOctober 23, 2023Highest risk

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharma

Prescription medicine · The Harvard Drug Group LLC dba Major… · 3718 saleable units affected

Failed Content Uniformity Specifications

Food & drug recall · FDAOctober 23, 2023Labelling issue

Glenmark Pharmaceuticals Inc., USA — Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 8,448 30-count bottles, 168 1000-count bottles affected

Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18…

Food & drug recall · FDAOctober 23, 2023Serious

Glenmark Pharmaceuticals Inc., USA — Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 16,944 bottles affected

Failed Dissolution Specifications: Out of specification for dissolution.

Food & drug recall · FDAOctober 20, 2023Labelling issue

Zyla Life Sciences US Inc. — Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only

Prescription medicine · Zyla Life Sciences US Inc. · 3,792 bottles affected

Sub-potent Drug: Lower potency than labeled.

Food & drug recall · FDAOctober 20, 2023Labelling issue

Glenmark Pharmaceuticals Inc., USA — Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 480 100-count bottles affected

Failed Impurities/Degradation Specifications

Food & drug recall · FDAOctober 20, 2023Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 2304 Bottles affected

Failed Impurities/Degradation Specifications.

Food & drug recall · FDAOctober 20, 2023Serious

Glenmark Pharmaceuticals Inc., USA — Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 5,856 bottles affected

Failed Dissolution Specifications

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