FDA Recall
TerminatedTerminated: March 11, 2019Historical recordClass II
0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09
by ICU Medical Inc
- Reason
- Presence of Particulate Matter; stainless steel
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 19, 2018Historical recordClass III
Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014
by Akorn Inc
- Reason
- Crystallization with subpotent out of specification assay results for chlorhexidine.
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 19, 2018Historical recordClass III
Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012
by Akorn Inc
- Reason
- Crystallization with subpotent out of specification assay results for chlorhexidine.
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 19, 2018Historical recordClass III
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.
by Akorn Inc
- Reason
- Crystallization with subpotent out of specification assay results for chlorhexidine.
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 7, 2020Historical recordClass I
Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy 9 Suite 600-441 Alpharetta, GA 30004
by DYNAMIC TECHNICAL FORMULATIONS
- Reason
- Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 5, 2020Historical recordClass I
D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1
by HARDCORE FORMULATIONS
- Reason
- Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 5, 2020Historical recordClass I
ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0
by HARDCORE FORMULATIONS
- Reason
- Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2018Historical recordClass III
Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940
by KVK-Tech, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 17, 2017Historical recordClass II
NatureAll-STF Holding, LLC
- Product
- Prostate-Plus, No. 117, 90 Capsules, Dietary Supplement
- Reason
- Undeclared allergens: soy (lecithin)
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 17, 2017Historical recordClass II
NatureAll-STF Holding, LLC
- Product
- Liver-Plus, No. 111 & 115, 120 Capsules, Dietary Supplement
- Reason
- Undeclared allergens: soy (lecithin)
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 17, 2017Historical recordClass I
NatureAll-STF Holding, LLC
- Product
- Metabo-Plus, Garlic/Papaya Plus, No. 103, 90 Capsules, Dieta…
- Reason
- Undeclared allergens: milk (Whey)
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: November 8, 2017Historical recordClass I
SIlver HIlls Bakery
- Product
- Aldi liveGfree Gluten Free Classic Soft White Hamburger Buns…
- Reason
- Undeclared eggs
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 14, 2017Historical recordClass II
High Liner Foods Inc.
- Product
- Sea Cuisine 8/9 oz., Pan Sear Garlic & Herb Tilapia. Item Nu…
- Reason
- Product may contain undeclared milk.
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 14, 2017Historical recordClass II
High Liner Foods Inc.
- Product
- Sea Cuisine 8/9 oz., Pan Sear Teriyaki Sesame Salmon. Item N…
- Reason
- Product may contain undeclared milk.
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 14, 2017Historical recordClass II
High Liner Foods Inc.
- Product
- Sea Cuisine 8/10.5 oz., Honey Chipotle Salmon. Item Number:…
- Reason
- Product may contain undeclared milk.
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 14, 2017Historical recordClass II
High Liner Foods Inc.
- Product
- HFS 1/20lb Whole Grain Oven Ready Corn Meal Breaded Alaska P…
- Reason
- Product may contain undeclared milk.
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 14, 2017Historical recordClass II
High Liner Foods Inc.
- Product
- HFS 1/20lb Whole Grain Nacho Encrusted Alaska Pollock Sticks…
- Reason
- Product may contain undeclared milk.
- Published
- August 23, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 14, 2017Historical recordClass II
High Liner Foods Inc.
- Product
- Kid Fresh 8/7.4oz Fish Sticks 0.53oz.., Item Number: B1412
- Reason
- Product may contain undeclared milk.
- Published
- August 23, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 14, 2017Historical recordClass II
High Liner Foods Inc.
- Product
- Sea Cuisine 8/9 oz Pan Sear Garlic & Herb Tilapia. Item Num…
- Reason
- Product may contain undeclared milk.
- Published
- August 23, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 14, 2017Historical recordClass II
High Liner Foods Inc.
- Product
- Sea Cuisine 20/10.75oz Honey Chipotle Crusted Salmon - Foam…
- Reason
- Product may contain undeclared milk.
- Published
- August 23, 2017
- 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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