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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 · FDANovember 26, 2025Labelling issue

SOMERSET THERAPEUTICS LLC — Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only

Prescription medicine · SOMERSET THERAPEUTICS LLC · 28,660 20mL vials affected

Subpotent product:out of specification assay results observed during long term stability testing.

Food & drug recall · FDANovember 26, 2025Labelling issue

SOMERSET THERAPEUTICS LLC — Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only

Prescription medicine · SOMERSET THERAPEUTICS LLC · 71,310 10mL vials affected

Subpotent product:out of specification assay results observed during long term stability testing.

Food & drug recall · FDANovember 26, 2025Labelling issue

Winder Laboratories, LLC — Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only

Prescription medicine · Winder Laboratories, LLC · 3,528 30 mL Bottles affected

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

Food & drug recall · FDANovember 26, 2025Serious

Golden State Medical Supply Inc. — Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only

Prescription medicine · Golden State Medical Supply Inc. · 2472 HDPE Bottles affected

Presence of Foreign Tablets/Capsules

Food & drug recall · FDANovember 24, 2025Serious

Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only

Prescription medicine · Breckenridge Pharmaceutical, Inc. · 7389 bottles affected

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Food & drug recall · FDANovember 24, 2025Serious

Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only

Prescription medicine · Breckenridge Pharmaceutical, Inc. · 3397 bottles affected

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Food & drug recall · FDANovember 21, 2025Labelling issue

Glenmark Pharmaceuticals Inc., USA — Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 11,136 bottles affected

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

Food & drug recall · FDANovember 20, 2025Serious

Fagron Compounding Services — Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St

Prescription medicine · Fagron Compounding Services · 2980 syringes affected

Incorrect Product Formulation

Food & drug recall · FDANovember 18, 2025Labelling issue

Glenmark Pharmaceuticals Inc., USA — Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 672 90-count bottles affected

Cross Contamination with Other Products

Food & drug recall · FDANovember 17, 2025Serious

Preferred Pharmaceuticals, Inc. — Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01

Prescription medicine · Preferred Pharmaceuticals, Inc. · 575 1x10 Foil Blister Packs affected

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…

Food & drug recall · FDANovember 14, 2025Serious

Cipla USA, Inc. — Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only

Prescription medicine · Cipla USA, Inc. · 12,576 bottles affected

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Food & drug recall · FDANovember 14, 2025Serious

Cipla USA, Inc. — Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only

Prescription medicine · Cipla USA, Inc. · 15,744 bottles affected

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Food & drug recall · FDANovember 14, 2025Serious

Cipla USA, Inc. — Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only

Prescription medicine · Cipla USA, Inc. · 63,504 bottles affected

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Food & drug recall · FDANovember 13, 2025Serious

Lupin Pharmaceuticals Inc. — Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only

Prescription medicine · Lupin Pharmaceuticals Inc. · 32736 vials affected

Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

Food & drug recall · FDANovember 11, 2025Labelling issue

Dr. Reddy's Laboratories, Inc. — Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

Prescription medicine · Dr. Reddy's Laboratories, Inc. · 4800 54-count bottles affected

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

Food & drug recall · FDANovember 7, 2025Labelling issue

Teva Pharmaceuticals USA, Inc — Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only

Prescription medicine · Teva Pharmaceuticals USA, Inc · 15,944 cartons affected

Defective Container - A defect in the side-seal which allows leakage of product.

Food & drug recall · FDANovember 6, 2025Highest risk

Fresenius Kabi USA, LLC — Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

Prescription medicine · Fresenius Kabi USA, LLC · 2,199,850 vials affected

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Food & drug recall · FDANovember 5, 2025Serious

Lupin Pharmaceuticals Inc. — Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only

Prescription medicine · Lupin Pharmaceuticals Inc. · 52,128 bottles affected

Defective container - seal not adhering to bottles

Food & drug recall · FDAOctober 31, 2025Serious

Novocol Pharmaceutical of Canada, Inc. — 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only

Prescription medicine · Novocol Pharmaceutical of Canada, Inc. · 18,789 cartons- 50 cartridges /carton affected

Defective container: cracked/broken cartridges

Food & drug recall · FDAOctober 31, 2025Serious

Novocol Pharmaceutical of Canada, Inc. — 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only

Prescription medicine · Novocol Pharmaceutical of Canada, Inc. · 5,825 affected

Defective container: cracked/broken cartridges

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