Agency
FDA drug recalls
Formal FDA enforcement reports for prescription and over-the-counter drugs — contamination, wrong potency, mislabeling, and manufacturing failures.
768 recalls in the last 12 months, translated into plain English.
- 2025-12-17CiplaClass IICinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- 2025-12-17CiplaClass IICinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- 2025-12-17Winder LaboratoriesClass IIIMorphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
- 2025-12-17GlenmarkClass IIINebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.
Cross Contamination with Other Products
- 2025-12-17FagronClass IITropicamide 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 N, Wichita, KS 67226. NDC: 71266-8240-01
Incorrect Product Formulation
- 2025-12-17LupinClass IIGanirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
- 2025-12-17Dr. Reddy'sClass IIIVarenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
- 2025-12-17CiplaClass IILanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.
Failed stability specifications: Out of specification for hardness test
- 2025-12-17CiplaClass IILanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.
Failed stability specifications: Out of specification for hardness test
- 2025-12-10BreckenridgeClass IIDuloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- 2025-12-10BreckenridgeClass IIDuloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- 2025-12-10Safecor HealthClass IIHaloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
- 2025-12-10Blossom PharmaceuticalsClass IIWecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
cGMP deviations
- 2025-12-10Blossom PharmaceuticalsClass IIGlobe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.
cGMP deviations
- 2025-12-10Blossom PharmaceuticalsClass IIGlobe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.
cGMP deviations
- 2025-12-10Blossom PharmaceuticalsClass IIGlobe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.
cGMP deviations
- 2025-12-10Blossom PharmaceuticalsClass IINivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.
cGMP deviations
- 2025-12-10Blossom PharmaceuticalsClass IINivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.
cGMP deviations
- 2025-12-10Blossom PharmaceuticalsClass IIDynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.
cGMP deviations
- 2025-12-10Blossom PharmaceuticalsClass IINivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15.
cGMP deviations
- 2025-12-10Blossom PharmaceuticalsClass IIWeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.
cGMP deviations
- 2025-12-10Blossom PharmaceuticalsClass IIDynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.
cGMP deviations
- 2025-12-10Blossom PharmaceuticalsClass IIWecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.
cGMP deviations
- 2025-12-10Blossom PharmaceuticalsClass IIDynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.
cGMP deviations
- 2025-12-10Blossom PharmaceuticalsClass IILanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.
cGMP deviations
- 2025-12-10Park Avenue CompoundingClass IIPhenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.
CGMP Deviations
- 2025-12-10GlenmarkClass IIIBisoprolol 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-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
- 2025-12-10TevaClass IIICarton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
Defective Container - A defect in the side-seal which allows leakage of product.
- 2025-12-10CiplaClass IIPhytonadione 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# 69097-708-31; Carton NDC 69097-708-96
Failed Stability Specifications: Observed OOS results: eg results for colour index
- 2025-12-03CA BotanaClass IIDr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8
CGMP Deviations
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