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Prescription Drugs

💊 Drugs • 12,141 recalls

EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.

Mckesson Medical-Surgical Inc. Corporate Office

Class I - Dangerous

CGMP Deviations; potential temperature excursions due to transit delays

Apr 21, 2025 Prescription Drugs View Details →

Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)

Cipla USA

Class I - Dangerous

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

Jun 30, 2025 Prescription Drugs Nationwide View Details →

Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01

Imprimis NJOF

Class I - Dangerous

Sub-Potent Drug: Subpotent assay results during stability testing.

Jul 9, 2025 Prescription Drugs Nationwide View Details →

clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01

Lupin Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.

Jun 27, 2025 Prescription Drugs Nationwide View Details →

BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.

Mckesson Medical-Surgical Inc. Corporate Office

Class I - Dangerous

CGMP Deviations; potential temperature excursions due to transit delays

Apr 21, 2025 Prescription Drugs View Details →

PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21

Mckesson Medical-Surgical Inc. Corporate Office

Class I - Dangerous

CGMP Deviations; potential temperature excursions due to transit delays

Apr 21, 2025 Prescription Drugs View Details →

Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01

Lupin Pharmaceuticals

Class I - Dangerous

Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

Jun 20, 2025 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17

ACCORD HEALTHCARE

Class I - Dangerous

Subpotent Drug: Assay below the approved specification

Jun 20, 2025 Prescription Drugs Nationwide View Details →

PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870.

Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles

Class I - Dangerous

Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.

Jul 1, 2025 Prescription Drugs View Details →

Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18

Ascend Laboratories

Class I - Dangerous

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Jul 9, 2025 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15

ACCORD HEALTHCARE

Class I - Dangerous

Subpotent Drug: Assay below the approved specification

Jun 20, 2025 Prescription Drugs Nationwide View Details →

Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01

Qualgen

Class I - Dangerous

Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

Jun 16, 2025 Prescription Drugs Nationwide View Details →

Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10

Dr. Reddy's Laboratories

Class I - Dangerous

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Jun 30, 2025 Prescription Drugs Nationwide View Details →

Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).

Jun 16, 2025 Prescription Drugs Nationwide View Details →