FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bakkavor Foods USA, Inc.
- Product
- Trader Joe's Tomato & Basil Hummus Dip, 7 oz. plastic contai…
- Reason
- Hummus was recalled due to potential Salmonella and/or Listeria monocytogenes contamination
- Published
- November 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bakkavor Foods USA, Inc.
- Product
- Trader Joe's Hummus quartet; 20 oz. plastic container; Spic…
- Reason
- Hummus was recalled due to potential Salmonella and/or Listeria monocytogenes contamination
- Published
- November 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
World Variety Produce Inc.
- Product
- Melissa's Hatch Chile Clean Snax, with Chia and flaxseed; 6.…
- Reason
- Firm discovered that Hatch Chile Clean Snax lists peanuts in the ingredient list but does not list peanuts under the allergen information.
- Published
- November 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11
by Upsher Smith Laboratories, Inc.
- Reason
- Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
by Upsher Smith Laboratories, Inc.
- Reason
- Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy LLC
- Reason
- Presence of precipitate
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450
by RXQ Compounding LLC
- Reason
- Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
by Teva Pharmaceuticals USA
- Reason
- Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
by Pfizer Inc.
- Reason
- Lack of assurance of sterility: loss of container integrity.
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31
by Heritage Pharmaceuticals, Inc.
- Reason
- Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60
by LUPIN SOMERSET
- Reason
- Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92
by Westlab Pharmacy, Inc. dba Westlab Pharmacy
- Reason
- Lack of Process Controls
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05
by Westlab Pharmacy, Inc. dba Westlab Pharmacy
- Reason
- Lack of Process Controls
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
by Westlab Pharmacy, Inc. dba Westlab Pharmacy
- Reason
- Incorrect Product Formulation
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11
by Lupin Pharmaceuticals Inc.
- Reason
- Defective Container: Repetitive complaints received indicating pump not working.
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80.
by Lannett Company, Inc.
- Reason
- CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29525 0.
by Product Quest Manufacturing LLC
- Reason
- Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12 Hour Pump Mist, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7000-01, UPC 3 11917 18535 4.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium Chloride as Preservatives), 1.5 FL OZ (44 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 58487 2.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Best Choice, 12 Hour No-Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 59895 4.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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