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FDA Drug Recalls

2,661 recalls, newest first

Class II · Moderate risk Ongoing Nov 24, 2025

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe…

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

Breckenridge Pharmaceutical, Inc. NDC 82009-032-10 D-0215-2026

Class III · Low risk Ongoing Nov 21, 2025

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b)…

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

Glenmark Pharmaceuticals Inc., USA D-0199-2026

Class II · Moderate risk Ongoing Nov 20, 2025

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For…

Reason Incorrect Product Formulation

Fagron Compounding Services D-0221-2026

Class III · Low risk Ongoing Nov 18, 2025

Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh…

Reason Cross Contamination with Other Products

Glenmark Pharmaceuticals Inc., USA NDC 42291-874-90 D-0222-2026

Class II · Moderate risk Ongoing Nov 17, 2025

Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred…

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

Preferred Pharmaceuticals, Inc. NDC 68788-8666-01 D-0239-2026

Class II · Moderate risk Ongoing Nov 14, 2025

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence…

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

Cipla USA, Inc. D-0226-2026

Class II · Moderate risk Ongoing Nov 14, 2025

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence…

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

Cipla USA, Inc. D-0225-2026

Class II · Moderate risk Ongoing Nov 14, 2025

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence…

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

Cipla USA, Inc. D-0224-2026

Class II · Moderate risk Ongoing Nov 13, 2025

Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured…

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

Lupin Pharmaceuticals Inc. NDC 70748-274-01 D-0220-2026

Class II · Moderate risk Ongoing Nov 12, 2025

Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL…

Reason Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis

Medical Products Laboratories, Inc. NDC 0363-3114-01 D-0179-2026

Class III · Low risk Ongoing Nov 11, 2025

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India…

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

Dr. Reddy's Laboratories, Inc. NDC 43598-908-56 D-0219-2026

Class III · Low risk Ongoing Nov 7, 2025

Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis…

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

Teva Pharmaceuticals USA, Inc NDC 0591-3216-30 D-0198-2026

Class I · High risk Ongoing Nov 6, 2025

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…

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

Fresenius Kabi USA, LLC NDC 63323-739-11 D-0182-2026

Class II · Moderate risk Ongoing Nov 5, 2025

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples…

Reason Defective container - seal not adhering to bottles

Lupin Pharmaceuticals Inc. NDC 68180-353-09 D-0227-2026

Class II · Moderate risk Ongoing Oct 31, 2025

OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only…

Reason Defective container: cracked/broken cartridges

Novocol Pharmaceutical of Canada, Inc. NDC 0362-0101-10 D-0234-2026

Class II · Moderate risk Ongoing Oct 31, 2025

Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose…

Reason Defective container: cracked/broken cartridges

Novocol Pharmaceutical of Canada, Inc. NDC 0362-0753-05 D-0233-2026

Class II · Moderate risk Ongoing Oct 31, 2025

Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton…

Reason Defective container: cracked/broken cartridges

Novocol Pharmaceutical of Canada, Inc. NDC 66975-406-51 D-0232-2026

Class II · Moderate risk Ongoing Oct 31, 2025

darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton…

Reason Defective container: cracked/broken cartridges

Novocol Pharmaceutical of Canada, Inc. NDC 66467-9760-5 D-0231-2026

Class II · Moderate risk Ongoing Oct 31, 2025

3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50…

Reason Defective container: cracked/broken cartridges

Novocol Pharmaceutical of Canada, Inc. NDC 66312-441-16 D-0230-2026

Class II · Moderate risk Ongoing Oct 31, 2025

Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50…

Reason Defective container: cracked/broken cartridges

Novocol Pharmaceutical of Canada, Inc. NDC 50227-1030-5 D-0229-2026

Class II · Moderate risk Ongoing Oct 31, 2025

2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50…

Reason Defective container: cracked/broken cartridges

Novocol Pharmaceutical of Canada, Inc. NDC 66312-176-16 D-0228-2026

Class II · Moderate risk Ongoing Oct 31, 2025

Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC…

Reason cGMP deviations

Blossom Pharmaceuticals NDC 67777-234-04 D-0213-2026

Class II · Moderate risk Ongoing Oct 31, 2025

Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA…

Reason cGMP deviations

Blossom Pharmaceuticals NDC 69396-086-02 D-0212-2026

Class II · Moderate risk Ongoing Oct 31, 2025

Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE…

Reason cGMP deviations

Blossom Pharmaceuticals NDC 69396-087-55 D-0211-2026

Class II · Moderate risk Ongoing Oct 31, 2025

Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue…

Reason cGMP deviations

Blossom Pharmaceuticals NDC 69396-087-01 D-0210-2026