FDA Recall
Completed
Historical recordClass II
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908
by Hetero Labs Limited Unit V
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307
by Hetero Labs Limited Unit V
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
- Published
- August 29, 2018
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0
by A-S Medication Solutions LLC.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0
by A-S Medication Solutions LLC.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
by A-S Medication Solutions LLC.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
by A-S Medication Solutions LLC.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Country Favor Inc.
- Product
- BEST TASTE BRAND SNACK GINGER SLICED, Net Weight 200g, 7 OZ,…
- Reason
- Product contains high levels of undeclared sulfites.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
SALT & STRAW LLC
- Product
- Chocolate Gooey Brownie Ice Cream, packaged in pint-sized co…
- Reason
- Chocolate Gooey Brownie Ice Cream is recalled due to possible undeclared peanuts.
- Published
- August 29, 2018
- Distribution
- Distributed in CA, OR, and WA. Firm a…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
J R Simplot Co Corporate HQ
- Product
- Simplot Good Grains Exotic Grains & Fire-Roasted Vegetable B…
- Reason
- Simplot Good Grains Exotic Grains & Fire-Roasted Vegetable Blend is recalled due to undeclared wheat.
- Published
- August 29, 2018
- Distribution
- distributed in CA, CO, CT, FL, GA, KS, M…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gift Services Inc Warehouse
- Product
- Sherman Candy Caramels are individually wrapped in plastic a…
- Reason
- Sherman Candy Caramels product is recalled due to undeclared pecans, walnuts, almonds and/or peanuts.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Natures Bounty Inc
- Product
- BLUE GREEN ALGAE: Packaged under the following brands: AMERI…
- Reason
- High level of microcystin observed in the product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dole Fresh Vegetables Inc
- Product
- Dole Classic Coleslaw, 14 oz. (397 g) plastic bag; Green C…
- Reason
- Recall of limited quantity of Classic Coleslaw due to potential for metal fragments in the product.
- Published
- August 29, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass III
Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99.
by Orexigen Therapeutics, Inc.
- Reason
- Defective Container: Customer complaints of punctures in the bottle.
- Published
- August 22, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
- Published
- August 22, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Severino Pasta Manufacturing, Inc.
- Product
- Severino Home Made, Artisanal Small Batch Pasta, Raviolini…
- Reason
- Severino Pasta Manufacturing, Inc. has initiated a recall of their Severino Pasta Super Fresh Cheese Raviolini due to undeclared eggs. The retail unit has the correct label on top, Cheese Raviolini which declares the precense of eggs in the ingredient statement and contains statement. However, the product has the incorrect label on the bottom, Cheese Rigatoni, which does not declare eggs in the ingredient statement or contains statement. The Raviolini label declares: Wheat, Milk, and Eggs whereas the Rigatoni label declares: Wheat and Milk. Since both labels are on the product consumers may be confused as to which ingredients are actually present.
- Published
- August 22, 2018
- Distribution
- Product was distributed to Whole Foods M…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Confidence Inc./Confidence U.S.A. Inc.
- Product
- FP0391 Confidence, Glucosamine Plus, With Hyaluronic Acid +…
- Reason
- Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG), Triacetin.
- Published
- August 22, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Confidence Inc./Confidence U.S.A. Inc.
- Product
- FP0692, Confidence, Prenatal Multi-V + DHA, 90 tablets per b…
- Reason
- Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG), Triacetin, FD&C Yellow #6 (Sunset Yellow FCF), FD&C Red #40 (Allura Red AC), FD&C Yellow #5 (Tartrazine), and FD&C Blue #2 (Indigotine).
- Published
- August 22, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Confidence Inc./Confidence U.S.A. Inc.
- Product
- FP0292 Confidence Nitro-Cross 60s, UPC# 8 92483 00155 7
- Reason
- Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol 400 and 800 (PEG), Triacetin
- Published
- August 22, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Confidence Inc./Confidence U.S.A. Inc.
- Product
- FP0392, Confidence, Glucosamine Plus, with White Willow Bark…
- Reason
- Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol 400 and 800 (PEG), Triacetin
- Published
- August 22, 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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