Drug and pharmaceutical recalls
17689 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIRacepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIAsthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIDakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIA&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIPataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIGenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIMiralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIDebrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IISystane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IISystane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIEye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IISystane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IINaphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIBisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IITriple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugHikma Pharmaceuticals USA Inc.Class IILorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- 2022-08-17FDA-DrugHikma Pharmaceuticals USA Inc.Class IILorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- 2022-08-17FDA-DrugHikma Pharmaceuticals USA Inc.Class IIAtivan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- 2022-08-17FDA-DrugHikma Pharmaceuticals USA Inc.Class IILorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- 2022-08-17FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IITelmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc,m USA, Mahwah, NJ 07430, NDC 68462-841-13.
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
- 2022-08-17FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IITelmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430, NDC 68462-842-13.
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
- 2022-08-10FDA-DrugUltra Supplement LLCClass ISUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
- 2022-08-10FDA-DrugDistributor RFR, LLC.Class ISANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
- 2022-08-10FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIITacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
Defective Container: Tube split from side seam
- 2022-08-10FDA-DrugTeva Pharmaceuticals USA IncClass IIMatzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.
Failed Dissolution Specifications: below specification limits for dissolution.
- 2022-08-10FDA-DrugTeva Pharmaceuticals USA IncClass IIMatzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA; NDC 52544-691-30.
Failed Dissolution Specifications: below specification limits for dissolution.
- 2022-08-10FDA-DrugTolmar, Inc.Class IINaftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510-63), c) Net Wt. 60g tube (NDC 0115-1510-58), Rx only, Manufactured by: Tolmar, Inc., Fort Collins, CO, 80526, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
- 2022-08-03FDA-DrugPfizer Inc.Class IPropofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Presence of particulate matter: particulate identified as a beetle.
- 2022-08-03FDA-DrugEco Lips, IncClass IIIJuice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566
Failed Dissolution Specifications
- 2022-08-03FDA-DrugEco Lips, IncClass IIIJuice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566
Failed Dissolution Specifications
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