FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sugar Foods Corporation Inc
- Product
- Fresh Gourmet Cubed Seasoned Croutons: 2.5 lb. foil pouch…
- Reason
- Recalled whey powder was used in further production of numerous food products.
- Published
- August 8, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sugar Foods Corporation Inc
- Product
- Kitchen Fixins Zesty Italian Croutons: 5 oz. foil pouch It…
- Reason
- Recalled whey powder was used in further production of numerous food products.
- Published
- August 8, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sugar Foods Corporation Inc
- Product
- Homestyle Seasoned Croutons: 4 oz. foil pouch Item # 73689…
- Reason
- Recalled whey powder was used in further production of numerous food products.
- Published
- August 8, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
General Mills, Inc
- Product
- Cheerios Protein Oats & Honey, Packaged in the following siz…
- Reason
- Cheerios Protein Oats and Honey cereal may be contaminated with Salmonella.
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
LL'S MAGNETIC CLAY INC
- Product
- Prescript-Assist Broad Spectrum Probiotic & Prebiotic Gastro…
- Reason
- The recalled dietary supplement has the potential to contain undeclared allergens, including almonds, shellfish, milk, eggs, and peanuts.
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
by Aidarex Pharmaceuticals LLC
- Reason
- Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
by Aidarex Pharmaceuticals LLC
- Reason
- Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
by Aidarex Pharmaceuticals LLC
- Reason
- Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5502-61.
by MAJOR PHARMACEUTICALS
- Reason
- Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5609-61.
by MAJOR PHARMACEUTICALS
- Reason
- Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40
by Sun Pharmaceutical Industries, Inc.
- Reason
- Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.
by MAJOR PHARMACEUTICALS
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
by MAJOR PHARMACEUTICALS
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Papa John's Salads & Produce, Inc.
- Product
- Superfood Salad Kit - 6.8 lbs. - sold to Kroger owned store…
- Reason
- It was discovered that a bulk salad kit was produced using the wrong components. Instead of cashews, peanuts were packed for the kit
- Published
- August 1, 2018
- Distribution
- AZ, CA, CO, MT, NM, NV, UT, and WY
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Sisel International Llc
- Product
- Sisel, SiselRipt, postWORKOUT, Dietary supplement, net wt 5g…
- Reason
- Firm is recalling SiselRipt due to the presence of an unapproved artificial sweetener, Cyclamates.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Prinova US LLC
- Product
- Prinova brand Product - Reginator NV (41825) 25 Kgs Fiber…
- Reason
- This recall has been identified due to the detection of cyclamates (artificial sweetener). Use of or consumption of cyclamates may include potential health hazard. Cyclamates and its salts (such as calcium cyclamate, sodium cyclamate, magnesium cyclamate, and potassium cyclamate) are currently prohibited from use in the United States.
- Published
- August 1, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Prinova US LLC
- Product
- Prinova brand Product - MRI Amintoten Strawberry Powder 25…
- Reason
- This recall has been identified due to the detection of cyclamates (artificial sweetener). Use of or consumption of cyclamates may include potential health hazard. Cyclamates and its salts (such as calcium cyclamate, sodium cyclamate, magnesium cyclamate, and potassium cyclamate) are currently prohibited from use in the United States.
- Published
- August 1, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Prinova US LLC
- Product
- Amino Life brand Product - BCAA 2:1:1 Instant Sunflower 25…
- Reason
- This recall has been identified due to the detection of cyclamates (artificial sweetener). Use of or consumption of cyclamates may include potential health hazard. Cyclamates and its salts (such as calcium cyclamate, sodium cyclamate, magnesium cyclamate, and potassium cyclamate) are currently prohibited from use in the United States.
- Published
- August 1, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Prinova US LLC
- Product
- Amino Life brand Product - L-Leucine Instant Sunflower 25…
- Reason
- This recall has been identified due to the detection of cyclamates (artificial sweetener). Use of or consumption of cyclamates may include potential health hazard. Cyclamates and its salts (such as calcium cyclamate, sodium cyclamate, magnesium cyclamate, and potassium cyclamate) are currently prohibited from use in the United States.
- Published
- August 1, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 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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