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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 · FDAMarch 21, 2024Serious

Lupin Pharmaceuticals Inc. — Rifampin Capsules USP, 300mg, 30-count bottles, Rx only

Prescription medicine · Lupin Pharmaceuticals Inc. · 26,352 bottles affected

Subpotent Drug

Food & drug recall · FDAMarch 21, 2024Highest risk

Amneal Pharmaceuticals of New York, LLC — Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Di

Prescription medicine · Amneal Pharmaceuticals of New York, LLC · 821 bottles affected

Superpotent Drug: Due to overfilling of drug powder

Food & drug recall · FDAMarch 12, 2024Serious

Eli Lilly & Company — Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton

Prescription medicine · Eli Lilly & Company · 700 vials affected

CGMP Deviations

Food & drug recall · FDAMarch 12, 2024Serious

Hikma Pharmaceuticals USA Inc. — Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only

Prescription medicine · Hikma Pharmaceuticals USA Inc. · 22,644 ampuls affected

The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.

Food & drug recall · FDAMarch 7, 2024Serious

Teva Pharmaceuticals USA, Inc — Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19

Prescription medicine · Teva Pharmaceuticals USA, Inc · 92,676 cartons affected

Failed Dissolution Specifications

Food & drug recall · FDAMarch 6, 2024Serious

B. Braun Medical Inc — Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20

Prescription medicine · B. Braun Medical Inc · 22,752 bags affected

Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label,…

Food & drug recall · FDAMarch 5, 2024Serious

Thea Pharma, Inc. — Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only

Prescription medicine · Thea Pharma, Inc. · 5,476 bottles affected

Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.

Food & drug recall · FDAMarch 4, 2024Labelling issue

Novitium Pharma LLC — Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only

Prescription medicine · Novitium Pharma LLC · 3,940 1000-count bottles affected

Cross Contamination with Other Products:(mycophenolate mofetil).

Food & drug recall · FDAMarch 4, 2024Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 47,520 bottles affected

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Food & drug recall · FDAMarch 4, 2024Highest risk

Par Sterile Products LLC — Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only

Prescription medicine · Par Sterile Products LLC · 466 vials affected

Presence of Particulate Matter.

Food & drug recall · FDAMarch 4, 2024Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 7,488 bottles affected

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Food & drug recall · FDAMarch 1, 2024Serious

Specialty Process Labs LLC — S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.

Prescription medicine · Specialty Process Labs LLC · 26 units affected

Failed Stability Specifications

Food & drug recall · FDAMarch 1, 2024Serious

Specialty Process Labs LLC — S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03

Prescription medicine · Specialty Process Labs LLC · 217 units affected

Failed Stability Specifications

Food & drug recall · FDAFebruary 29, 2024Serious

SSM Health Care St. Louis DBA SSM St. Clare Health Center — Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corpo

Prescription medicine · SSM Health Care St. Louis DBA SSM St.… · 11,798 syringes affected

Lack of Assurance of Sterility: Firm did not perform process validation.

Food & drug recall · FDAFebruary 29, 2024Serious

SSM Health Care St. Louis DBA SSM St. Clare Health Center — FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Ou

Prescription medicine · SSM Health Care St. Louis DBA SSM St.… · 140 vials affected

Lack of Assurance of Sterility: Firm did not perform process validation.

Food & drug recall · FDAFebruary 22, 2024Serious

Eugia US LLC — Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06

Prescription medicine · Eugia US LLC · 1160 VIALS affected

Failed Stability Specification: Water determination was found not complying with specification.

Food & drug recall · FDAFebruary 20, 2024Serious

Denver Solutions, LLC DBA Leiters Health — Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42

Prescription medicine · Denver Solutions, LLC DBA Leiters Health · 40,090 vials affected

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Food & drug recall · FDAFebruary 20, 2024Serious

Denver Solutions, LLC DBA Leiters Health — Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42

Prescription medicine · Denver Solutions, LLC DBA Leiters Health · 40,890 vials affected

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Food & drug recall · FDAFebruary 20, 2024Labelling issue

Contract Pharmaceuticals Limited Canada — Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only

Prescription medicine · Contract Pharmaceuticals Limited Canada · 45,875 bottles affected

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Food & drug recall · FDAFebruary 20, 2024Labelling issue

Contract Pharmaceuticals Limited Canada — Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle

Prescription medicine · Contract Pharmaceuticals Limited Canada · 11,750 bottles affected

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

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