FDA Recall United States Terminated Historical recordClass II
Superior Foods Company
- Product
- Park Street Deli Cinnamon Bun Dessert Dip Net WT 7oz. in pla…
- Reason
- foreign material (plastic)
- Published
- August 20, 2025
- Distribution
- Nationwide
Data Explorer
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Recall totals
All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.
37,059
Total recall recordsAll FDA and USDA recalls in Public Health Trace9,786
Class I recallsReasonable probability of serious health consequences24,313
Class II recallsTemporary or medically reversible health consequences2,876
Class III recallsNot likely to cause adverse health consequencesQuick insights
A snapshot of the most notable patterns across all recorded FDA and USDA recalls.
Most recalled product100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
53 recalls
Most common hazardLack of Assurance of Sterility
2,072 recalls
Download matching recalls as CSV
CSV exports include up to 5,000 matching rows (applying your current filters), not the full dataset if it's larger.
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A chart of recalls grouped by month.
Download CSVSummary (Year to date)
- 1,527 recalls have been announced year to date.
- Aug 2026 was 24% lower than the previous complete period (Jul 2026: 240).
- The highest complete period was Jun 2026 (297).
- Sep 2026 is incomplete and not included in the figures above.
- Complete data
- Incomplete
A bar chart of the total number of recalls in this dataset by recall class.
| Class | Recalls |
|---|---|
| Class II | 24,313 |
| Class I | 9,786 |
| Class III | 2,876 |
| Not Yet Classified | 2 |
| Class | Recalls |
|---|---|
| Class II | 24,313 |
| Class I | 9,786 |
| Class III | 2,876 |
| Not Yet Classified | 2 |
FDA Recall Ongoing Historical recordClass II
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01
- Reason
- Presence of foreign substance: identified as aluminum.
- Published
- August 13, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
- Reason
- CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- Published
- August 13, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
- Reason
- CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- Published
- August 13, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
- Reason
- CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- Published
- August 13, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
- Reason
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Published
- August 13, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
- Reason
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Published
- August 13, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31
- Reason
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Published
- August 13, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
- Published
- August 13, 2025
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass II
QUEEN BEE GARDENS
- Product
- Brand Name: Queen Bee Gardens Whipped Honey Huckleberry Inte…
- Reason
- Product may have small flakes of stainless steel in product.
- Published
- August 13, 2025
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass II
QUEEN BEE GARDENS
- Product
- Brand Name: Queen Bee Gardens Whipped Honey Pure. Intended u…
- Reason
- Product may have small flakes of stainless steel in product.
- Published
- August 13, 2025
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass II
QUEEN BEE GARDENS
- Product
- Brand Name: Queen Bee Gardens Whipped Honey Raspberry. Inte…
- Reason
- Product may have small flakes of stainless steel in product.
- Published
- August 13, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
- Reason
- Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
- Published
- August 6, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
- Reason
- CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
- Published
- August 6, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
- Reason
- Failed Dissolution Specifications.
- Published
- August 6, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04
- Reason
- CGMP Deviations; particulates identified during visual inspection
- Published
- August 6, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02
- Reason
- CGMP Deviations; particulates identified during visual inspection
- Published
- August 6, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
- Reason
- Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
- Published
- August 6, 2025
- Distribution
- Nationwide
FDA Recall Completed Historical recordClass II
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
- Published
- August 6, 2025
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass II
NuNaturals Inc
- Product
- Pure Monk Fruit Sweetener, net wt. 0.71oz. UPC 7 39223 00187…
- Reason
- Product is Stevia powder but bottle was mis-labeled as Pure Monk Fruit Sweetener.
- Published
- August 6, 2025
- Distribution
- Nationwide
Data last updated:
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. Read the full medical disclaimer.
