FDA Recall
Terminated
Historical recordClass III
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
by Akorn, Inc.
- Reason
- Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
by Amneal Pharmaceuticals
- Reason
- Presence of particulate matter
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27
by Paddock Laboratories, LLC.
- Reason
- Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
by Renaissance Lakewood, LLC
- Reason
- Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pinks Bakery Seattle, Inc.
- Product
- Variety Pack, Marsee Baking brand, eight 3.2oz cookies indiv…
- Reason
- Coconut is listed in the ingredient statement but is not declared in the Contains statement
- Published
- April 4, 2018
- Distribution
- distributed in OR and WA.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pinks Bakery Seattle, Inc.
- Product
- Hippie Cookie, Marsee Baking brand, six 3.2oz cookies indivi…
- Reason
- Coconut is listed in the ingredient statement but is not declared in the Contains statement
- Published
- April 4, 2018
- Distribution
- distributed in OR and WA.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Schwartz Brothers Restaurants dba Schwartz Brothers Bakery
- Product
- Gourmet Cream Cheese Cinnamon Rolls, packaged in a 16 oz. pl…
- Reason
- Gourmet Cream Cheese Cinnamon Roll is recalled due to undeclared egg.
- Published
- April 4, 2018
- Distribution
- distributed in WA
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Piggie Park Enterprises Inc
- Product
- Maurice's Honey Southern Gold BBQ Sauce; Net Wt. 18 oz. bott…
- Reason
- Undeclared soy and wheat ingredients
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Taylor Farms California Foodservice, Inc.
- Product
- Taylor Farms 3/8" Diced Yellow Onion 4/5# bags - 20 lb, corr…
- Reason
- Firm was notified by direct customer of a confirmed positive result for Salmonella ssp. after routine testing of the diced onion product.
- Published
- April 4, 2018
- Distribution
- OK, OH, MI, MN, IA, CA, KS, WI, PA, OR,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Oregon Wild Berries, Inc.
- Product
- Mushroom Condensed Soup, brand Chef Edwin's, packaged in gla…
- Reason
- Mushroom Condensed Soup, packaged in glass pint Kerr jars, is recalled due to under-processed or the venting schedule was not followed.
- Published
- April 4, 2018
- Distribution
- distributed in Oregon and Washington
View recall →
FDA Recall
Terminated
Historical recordClass III
Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
- Published
- March 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Ikea North America Srvcs Inc
- Product
- Pink flexible, plastic package: Godis Paskkyckling Marshm…
- Reason
- Possible Pest Contamination at production facility.
- Published
- March 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Oregon Food Bank
- Product
- Chia Seeds packaged in poly film bags as both a twist type c…
- Reason
- Chia Seeds, 1 lb. packages, are recalled because they are contaminated with rodent droppings.
- Published
- March 28, 2018
- Distribution
- distributed in Oregon and Washington
View recall →
FDA Recall
Terminated
Historical recordClass II
Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India NDC # 31722-705-30
by Hetero Labs Limited Unit V
- Reason
- Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60
by Hetero Labs Limited Unit V
- Reason
- Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038
by Novel Laboratories, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01
by Pfizer Inc.
- Reason
- Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01
by Pfizer Inc.
- Reason
- Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
- Published
- March 21, 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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