FDA Recall
TerminatedTerminated: August 6, 2025Historical recordClass II
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Failed Dissolution Specifications
- Published
- November 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 27, 2024Historical recordClass III
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
by Taro Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05
by Par Sterile Products LLC
- Reason
- Crystallization; identified as Buprenorphine free base
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 9, 2024Historical recordClass II
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- Ready Set Serve 4/5 LB CTN FRESH 1/4" DICED YLW ONIONS W/ZIP
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- Ready Set Serve 2/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/…
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- PEAK 4/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIPPER
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- PEAK 2/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIP
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- PEAK 2/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIP
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- Imperial Fresh 2/5 LB CTN FRESH 1/4" SLIVERED YLW ONIONS W/Z…
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- Imperial Fresh 2/5 LB CTN FRSH 1/4" DICED YLW ONIONS W/ZIP
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- Imperial Fresh 2/5 LB CTN FRSH 1/4" DICED RED ONIONS W/ZIPPE…
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- 4/5 LB CTN FRESH 1/4" DICED YLW ONIONS W/ZIPPER DARDEN
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- Gills Onions 2/5 LB CTN FRESH 3/8" DICED RED ONIONS WITH ZIP…
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- Gills Onions 1/5 LB CTN FRESH 1/4" DICED RED ONIONS W/ZIPPER
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- Cross Valley Farms 2/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS…
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- Cross Valley Farms 2/5 LB CTN FRESH 3/8" DICED RED ONIONS W/…
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
Gills Onions, LLC
- Product
- Gills Onions 8 oz cups, diced celery & onions
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 18, 2024Historical recordClass II
Nutricia North America
- Product
- Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packag…
- Reason
- Incorrect product in packaging
- Published
- November 15, 2023
- Distribution
- 247 kits shipped within US (Alabama, Cal…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 10, 2025Historical recordClass III
The Sausage Maker, Inc.
- Product
- The Sausage Maker Instacure #1
- Reason
- Contains Sodium Nitrite recalled for potential metal contamination
- Published
- November 15, 2023
- 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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