Drug and pharmaceutical recalls
17658 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2025-04-09FDA-DrugImprimis NJOF, LLCClass IIITropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
- 2025-04-09FDA-DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesClass IIITolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
- 2025-04-02FDA-DrugExela Pharma Sciences LLCClass II8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4
Lack of Assurance of Sterility
- 2025-04-02FDA-DrugConsumer Product Partners, LLCClass II[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle, WA 98109.
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
- 2025-04-02FDA-DrugAscent Consumer Products Inc.Class ISinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
- 2025-04-02FDA-DrugAscent Consumer Products Inc.Class ISinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
- 2025-04-02FDA-DrugAscent Consumer Products Inc.Class ISinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
- 2025-04-02FDA-DrugJohnson, S C and Son, IncClass IIbabyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
- 2025-04-02FDA-DrugQuVa Pharma, Inc.Class IIfentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75
Lack of Assurance of Sterility
- 2025-04-02FDA-DrugQuVa Pharma, Inc.Class IIfentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75
Lack of Assurance of Sterility
- 2025-04-02FDA-DrugQuVa Pharma, Inc.Class IIfentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75
Lack of Assurance of Sterility
- 2025-04-02FDA-DrugStrides Pharma, Inc.Class IITestosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02
Presence of foreign substance: Presence of Benzene.
- 2025-04-02FDA-DrugStrides Pharma, Inc.Class IITestosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02
Presence of foreign substance: Presence of Benzene.
- 2025-04-02FDA-DrugA-S Medication Solutions LLCClass IIMETFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.
Presence of Foreign Tablets/Capsules.
- 2025-03-26FDA-DrugMylan Institutional, Inc.Class IILevothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.
Super-Potent Drug: Out of specification potency results were obtained.
- 2025-03-26FDA-DrugMylan Institutional, Inc.Class IILevothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.
Super-Potent Drug: Out of specification potency results were obtained.
- 2025-03-26FDA-DrugMEDLINE INDUSTRIES, LP - NorthfieldClass IICURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30.
Subpotent Drug
- 2025-03-26FDA-DrugMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
Subpotent Drug
- 2025-03-26FDA-DrugGolden State Medical Supply Inc.Class IIPRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30
Failed Dissolution Specifications
- 2025-03-26FDA-DrugAmgen, Inc.Class IINeupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box).
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
- 2025-03-26FDA-DrugAmgen, Inc.Class IINeupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box).
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
- 2025-03-26FDA-DrugFruit Of The Earth, Inc.Class IICVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
Chemical contamination: presence of benzene
- 2025-03-26FDA-DrugFruit Of The Earth, Inc.Class IIWalgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
Chemical contamination: presence of benzene
- 2025-03-26FDA-DrugFDC LimitedClass IICiprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
- 2025-03-26FDA-DrugOne Source Nutrition, Inc,Class IVitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
- 2025-03-26FDA-DrugMYLAN PHARMACEUTICALS INCClass IIPrasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
Failed Dissolution Specifications - low dissolution results
- 2025-03-26FDA-DrugSlate Run PharmaceuticalsClass IICinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
- 2025-03-26FDA-DrugSlate Run PharmaceuticalsClass IICinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
- 2025-03-26FDA-DrugRising Pharma Holding, Inc.Class IIDuloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- 2025-03-19FDA-DrugJohnson, S C and Son, IncClass IIKids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916
Chemical Contamination
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