FDA Recall
Terminated
Historical recordClass III
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30
by Aurobindo Pharma USA Inc.
- Reason
- Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
- Published
- December 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ottogi America Inc
- Product
- Ottogi Jin Ramen Mild NET WT. 1lb 5.16oz, 600g (120gx5) 5P…
- Reason
- Undeclared allergen; egg.
- Published
- December 12, 2018
- Distribution
- U.S. distribution to the following: CA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ottogi America Inc
- Product
- Ottogi Jin Ramen Spicy NET WT. 1lb 5.16oz, 600g (120gx5) 5…
- Reason
- Undeclared allergen; egg.
- Published
- December 12, 2018
- Distribution
- U.S. distribution to the following: CA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Agropur MSI Ingredients LLC
- Product
- Jay Robb Unflavored Egg White Protein, Net Weight 24 oz (1.5…
- Reason
- JayRobb Unflavored Egg White Protein Product is being recalled due to undeclared milk.
- Published
- December 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc.
- Product
- 16 count Crunch & Pop Mix Variety Pack Sack
- Reason
- The firm is recalling 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn packaged in two variety pack offerings. The popcorn bags have the potential to contain cheese-flavored chips and therefore undeclared milk.
- Published
- December 12, 2018
- Distribution
- Alabama, Arkansas, Colorado, Florida, Ge…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc.
- Product
- 16 count Smartfood Delight Variety Pack Sack
- Reason
- The firm is recalling 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn packaged in two variety pack offerings. The popcorn bags have the potential to contain cheese-flavored chips and therefore undeclared milk.
- Published
- December 12, 2018
- Distribution
- Alabama, Arkansas, Colorado, Florida, Ge…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Smartypants Vitamins
- Product
- Smartypants Kids Complete, Non GMO Multi and omega 3's vit…
- Reason
- Consumer complaints of finding foreign objects in bottles of gummy vitamins.
- Published
- December 12, 2018
- Distribution
- WA, IL, RI, MC, NJ, ID, IA, VA, NY, OH,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Rich Products Corp
- Product
- VANILLA WHIPPED ICING ARTIFICALLY FLAVORED Product Number: 0…
- Reason
- Possible contamination with cleaning chemicals.
- Published
- December 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1
by Ascend Laboratories LLC
- Reason
- Presence of Foreign Substance; metal shard found in tablet
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ConAgra Foods, INc.
- Product
- Duncan Hines Signature Confetti Cake cake mix 15.25oz.…
- Reason
- positive finding of Salmonella in a retail sample
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ConAgra Foods, INc.
- Product
- Duncan Hines Classic Butter Golden cake mix 15.25oz. 12…
- Reason
- positive finding of Salmonella in a retail sample
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ConAgra Foods, INc.
- Product
- Duncan Hines Classic Classic Yellow cake mix 15.25oz. 1…
- Reason
- positive finding of Salmonella in a retail sample
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ConAgra Foods, INc.
- Product
- Duncan Hines Classic Classic White cake mix 15.25oz. 12…
- Reason
- positive finding of Salmonella in a retail sample
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Chicago Importing Co
- Product
- Finax Muesli with 45% Fruit; 22.9-oz.; Heat sealed plastic…
- Reason
- The product's ingredients statement does not indicate presence of coconut
- Published
- December 5, 2018
- Distribution
- AZ CA FL IL MA MD MI MN NJ NY…
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FDA Recall
Terminated
Historical recordClass II
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-503-59
by Ecolab Inc
- Reason
- Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-521-41
by Ecolab Inc
- Reason
- Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11)
by American Health Packaging
- Reason
- Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
by Sciegen Pharmaceuticals Inc
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- November 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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