FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Griffith Labs U.S.A.
- Product
- Low Sodium Brown Gravy Mix 12 oz unit, 8 units per carton…
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Griffith Labs U.S.A.
- Product
- Beef Flavored Gravy Mix 12 oz unit, 8 units per carton Ite…
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Griffith Labs U.S.A.
- Product
- Brown Gravy Mix 16 oz unit, 24 units per carton Item 10000…
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Griffith Labs U.S.A.
- Product
- Queso Snack Seasoning 25 pound bag, 1 bags per carton Item…
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Griffith Labs U.S.A.
- Product
- Milk and Egg Mix 12 oz bag, 32 bags per carton Item 10000…
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Griffith Labs U.S.A.
- Product
- Dry Milk and Egg Mix 12 oz bag, 24 bags per carton Item 9…
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Griffith Labs U.S.A.
- Product
- Biscuit Mix 4.5 pound bag, 8 bags per carton Item 12704230…
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 19, 2019Historical 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
TerminatedTerminated: February 8, 2019Historical 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
TerminatedTerminated: December 4, 2019Historical 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
TerminatedTerminated: December 4, 2019Historical 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
TerminatedTerminated: December 4, 2019Historical 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
TerminatedTerminated: April 10, 2019Historical 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
TerminatedTerminated: April 10, 2019Historical 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
TerminatedTerminated: March 11, 2019Historical 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
TerminatedTerminated: October 2, 2022Historical 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
TerminatedTerminated: October 2, 2022Historical 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
TerminatedTerminated: October 25, 2018Historical recordClass II
Biscomerica, Inc.
- Product
- Sweet Serenity Caramel Sea Salt Chocolate Chip Cookies, wit…
- Reason
- Product labeling does not list milk in the contains statement; however milk is listed as in ingredient.
- Published
- August 1, 2018
- Distribution
- CT, NJ, GA, FL, TN, TX, IL, OH, MI, MO,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 8, 2018Historical recordClass III
Orca Bay Foods LLC
- Product
- Consumer Packaging: WELLSLEY FARM WILD CAUGHT MAHI-MAHI LOIN…
- Reason
- Product is decomposed.
- Published
- August 1, 2018
- Distribution
- Retail product distributed in FL and NC…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 13, 2018Historical 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 →
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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