FDA Recall
Terminated
Historical recordClass III
buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
by InvaGen Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications; during stability testing
- Published
- April 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03
by InvaGen Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications; during stability testing
- Published
- April 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
by Mayne Pharma Inc
- Reason
- Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
- Published
- April 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
First Source, LLC
- Product
- Wegmans Yogurt Raisins, 9 OZ (255g), in a plastic tub, UPC:…
- Reason
- Product contains undeclared peanuts.
- Published
- April 11, 2018
- Distribution
- Wegmans Stores in MA, MD, NJ, NY, PA and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Natural Grocers by Vitamin Cottage
- Product
- Natural Grocers Organic Coconut Smiles, 10 oz. plastic resea…
- Reason
- Coconut smiles product tested positive for Salmonella.
- Published
- April 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
International Harvest, Inc.
- Product
- Coconut Smiles - Retail: International Harvest Brand Organic…
- Reason
- Product tested positive for Salmonella.
- Published
- April 11, 2018
- Distribution
- Directly distributed to the following st…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ventura Foods, LLC
- Product
- Gordon Choice Asian Sesame Ginger Dressing, Net Contents/Con…
- Reason
- A blue plastic bag was inadvertently introduced into product stream. During the manufacturing process, the blue plastic bag was torn into many pieces and ended up in the finished product. While many pieces of the blue plastic bag have been recovered, there is no evidence that all pieces are accounted for.
- Published
- April 11, 2018
- Distribution
- NJ
View recall →
FDA Recall
Terminated
Historical recordClass III
24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97014.
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 III
24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97012.
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 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
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
Wegmans Food Markets, Inc.
- Product
- Wegmans Assorted Gyoza (Dumplings), Family Pack, 17 oz. UP…
- Reason
- The product is labeled as Thai Chili Sauce. The product actually contains Spicy Sauce which contains undeclared egg.
- Published
- April 4, 2018
- Distribution
- Wegmans Stores in NY, NJ, PA, VA, MD and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wegmans Food Markets, Inc.
- Product
- Wegmans Avocado Summer Roll, 2 Pack, 5 oz. UPC: 2-48762-0000…
- Reason
- The product is labeled as Thai Chili Sauce. The product actually contains Spicy Sauce which contains undeclared egg.
- Published
- April 4, 2018
- Distribution
- Wegmans Stores in NY, NJ, PA, VA, MD and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wegmans Food Markets, Inc.
- Product
- Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (UPC 7-66630-9802…
- Reason
- The product is labeled as Thai Chili Sauce. The product actually contains Spicy Sauce which contains undeclared egg.
- Published
- April 4, 2018
- Distribution
- Wegmans Stores in NY, NJ, PA, VA, MD and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mondelez Global Llc
- Product
- Sour Patch Kids, 1.9 lb bag
- Reason
- Mondelez Global LLC is initiating a recall because remnants of a half peanut shell were found in two containers of bulk candy from a single lot during the repacking process and the candy is not labeled as containing peanuts. Mondelez Global LLC after an investigation, including inspection of product within in their control from the same lot did not find any other evidence of peanut contamination. The firm believes this is most likely to be an isolated incident and that product on the market is unlikely to contain any peanut pieces and the product is not likely to cause adverse health consequences to peanut allergic consumers. No adverse health events have been reported. Never the less, out of an abundance of caution, we have determined to conduct a voluntary recall to the retail level.
- Published
- April 4, 2018
- Distribution
- The product has been distributed to the…
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 →
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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