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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

1,991 recalls · newest first

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, 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. — OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc.

Prescription medicine · Novocol Pharmaceutical of Canada, Inc. · 1,636 cartons affected

Defective container: cracked/broken cartridges

Food & drug recall · FDAOctober 31, 2025Serious

Blossom Pharmaceuticals — Wecare Enema, 4.5 Fl Oz/133mL

Prescription medicine · Blossom Pharmaceuticals · 18912 containers affected

cGMP deviations

Food & drug recall · FDAOctober 31, 2025Serious

Novocol Pharmaceutical of Canada, Inc. — darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactur

Prescription medicine · Novocol Pharmaceutical of Canada, Inc. · 5,520 Cartons affected

Defective container: cracked/broken cartridges

Food & drug recall · FDAOctober 31, 2025Serious

Blossom Pharmaceuticals — Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g)

Prescription medicine · Blossom Pharmaceuticals · 1560 containers affected

cGMP deviations

Food & drug recall · FDAOctober 31, 2025Serious

Novocol Pharmaceutical of Canada, Inc. — Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distribut

Prescription medicine · Novocol Pharmaceutical of Canada, Inc.

Defective container: cracked/broken cartridges

Food & drug recall · FDAOctober 31, 2025Serious

Novocol Pharmaceutical of Canada, Inc. — Lidocaine HCI 2% and 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. · 12,033 cartons affected

Defective container: cracked/broken cartridges

Food & drug recall · FDAOctober 31, 2025Serious

Blossom Pharmaceuticals — Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.

Prescription medicine · Blossom Pharmaceuticals · 9600 containers affected

cGMP deviations

Food & drug recall · FDAOctober 31, 2025Serious

Blossom Pharmaceuticals — Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g)

Prescription medicine · Blossom Pharmaceuticals · 8184 bottles affected

cGMP deviations

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

Food & drug recall · FDAOctober 31, 2025Serious

Blossom Pharmaceuticals — Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g

Prescription medicine · Blossom Pharmaceuticals · 14700 bottles affected

cGMP deviations

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

Blossom Pharmaceuticals — Wecare Calasoothe, Net wt. 4 oz (113 g)

Prescription medicine · Blossom Pharmaceuticals · 2400 containers affected

cGMP deviations

Food & drug recall · FDAOctober 31, 2025Serious

Cipla Limited — Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708

Prescription medicine · Cipla Limited · 4,438 10x1mL cartons affected

Failed Stability Specifications: Observed OOS results: eg results for colour index

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