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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 · 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, 2024Serious

Eugia US LLC — Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01

Prescription medicine · Eugia US LLC · 10,080 vials affected

Failed Dissolution Specifications

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 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.

Food & drug recall · FDAFebruary 15, 2024Highest risk

Eugia US LLC — Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10

Prescription medicine · Eugia US LLC · 1,552 10ml x 25/carton affected

Presence of Particulate Matter

Food & drug recall · FDAFebruary 13, 2024Serious

Amneal Pharmaceuticals of New York, LLC — Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only

Prescription medicine · Amneal Pharmaceuticals of New York, LLC · 46,037 Bottles affected

Failed Impurities/Degradation Specifications: Out-of-specification test results.

Food & drug recall · FDAFebruary 12, 2024Serious

Micro Labs Limited — Clobazam Tablets 10mg, 100-count bottle, Rx Only

Prescription medicine · Micro Labs Limited · 24,768 bottles affected

CGMP Deviations: Out of specification for residual solvents.

Food & drug recall · FDAFebruary 12, 2024Serious

MCKESSON CORPORATION — CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g

Prescription medicine · MCKESSON CORPORATION · 42 units affected

CGMP Deviations: Product was stored outside labeled storage temperature requirements.

Food & drug recall · FDAFebruary 9, 2024Labelling issue

Stason Pharmaceuticals, Inc. — Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only

Prescription medicine · Stason Pharmaceuticals, Inc. · 54, 131 bottles affected

Failed Dissolution Specifications: results slightly under spec at at 9-months.

Food & drug recall · FDAFebruary 9, 2024Serious

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only

Prescription medicine · The Harvard Drug Group LLC dba Major… · 8,198 units affected

an out of specification result obtained during routine stability testing for Impurities.

Food & drug recall · FDAFebruary 9, 2024Serious

Micro Labs Limited — Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle

Prescription medicine · Micro Labs Limited · 118,080 bottles affected

Failed Stability Specifications: Out of specification for blend uniformity.

Food & drug recall · FDAFebruary 7, 2024Serious

Mckesson Medical-Surgical Inc. Corporate Office — Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10

Prescription medicine · Mckesson Medical-Surgical Inc. Corporate… · 70 vials affected

cGMP Deviations: Products were stored outside the drug label specifications.

Food & drug recall · FDAFebruary 7, 2024Serious

Mckesson Medical-Surgical Inc. Corporate Office — Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10

Prescription medicine · Mckesson Medical-Surgical Inc. Corporate… · 70 vials affected

cGMP Deviations: Products were stored outside the drug label specifications.

Food & drug recall · FDAFebruary 6, 2024Serious

Mallinckrodt Hospital Products Inc. — Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1

Prescription medicine · Mallinckrodt Hospital Products Inc. · 8 vials involved in recall (16,479 vials distributed) affected

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor.

Food & drug recall · FDAFebruary 6, 2024Serious

Mallinckrodt Hospital Products Inc. — Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only

Prescription medicine · Mallinckrodt Hospital Products Inc. · 421 vials involved in this recall (2,448 vials distributed) affected

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor.

Food & drug recall · FDAFebruary 5, 2024Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 54,960 bottles affected

Failed Dissolution Specifications: Out of specification for dissolution.

Food & drug recall · FDAFebruary 5, 2024Serious

Lupin Pharmaceuticals Inc. — Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute

Prescription medicine · Lupin Pharmaceuticals Inc. · N/A affected

Labeling: Incorrect or Missing Package Insert

Food & drug recall · FDAFebruary 5, 2024Highest risk

Super Chill Products — Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle

Prescription medicine · Super Chill Products · 3,573 bottles affected

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

Food & drug recall · FDAFebruary 2, 2024Serious

Bausch Health Companies, Inc. — Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup contai

Prescription medicine · Bausch Health Companies, Inc. · 3,600 cartons affected

Subpotent Drug: Out of specification for assay

Food & drug recall · FDAFebruary 1, 2024Labelling issue

Amerisource Health Services LLC — HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only

Prescription medicine · Amerisource Health Services LLC · 2,850 cartons affected

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the…

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