FDA Recall Terminated Historical recordClass I
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
- Reason
- Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
- Published
- October 15, 2014
- Distribution
- Nationwide
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Recall totals
All FDA and USDA recalls in Public Health Trace, June 2012 to October 2026.
37,211
Total recall recordsAll FDA and USDA recalls in Public Health Trace9,841
Class I recallsReasonable probability of serious health consequences24,366
Class II recallsTemporary or medically reversible health consequences2,892
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
2,073 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)
- 1,714 recalls have been announced year to date.
- Sep 2026 was 3% higher than the previous complete period (Aug 2026: 182).
- The highest complete period was Jun 2026 (297).
- Oct 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 | 24,366 |
| Class I | 9,841 |
| Class III | 2,892 |
| Not Yet Classified | 2 |
| Class | Recalls |
|---|---|
| Class II | 24,366 |
| Class I | 9,841 |
| Class III | 2,892 |
| Not Yet Classified | 2 |
FDA Recall Terminated Historical recordClass II
METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.
- Reason
- Defective Container: Product leaks when inverted.
- Published
- October 15, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.
- Reason
- Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol
- Published
- October 15, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
- Reason
- Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
- Published
- October 15, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01
- Reason
- Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
- Published
- October 15, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
- Reason
- Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
- Published
- October 15, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, IL 61103, NDC 67457-153-09.
- Reason
- Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
- Published
- October 15, 2014
- Distribution
- McKesson Medical-Surgical Inc distribute…
FDA Recall Terminated Historical recordClass II
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.
- Reason
- Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
- Published
- October 8, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.
- Reason
- Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
- Published
- October 8, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82
- Reason
- Lack of Assurance of Sterility; leaking of premix bags
- Published
- October 8, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663
- Reason
- Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
- Published
- October 8, 2014
- Distribution
- To retailers in MD, TX, FL, PA, IL, NJ,…
FDA Recall Terminated Historical recordClass I
Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd.
- Reason
- Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
- Published
- October 8, 2014
- Distribution
- To retailers in MD, TX, FL, PA, IL, NJ,…
FDA Recall Terminated Historical recordClass I
AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.
- Reason
- Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
- Published
- October 8, 2014
- Distribution
- To retailers in MD, TX, FL, PA, IL, NJ,…
FDA Recall Terminated Historical recordClass II
CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07.
- Reason
- Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
- Published
- October 8, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.
- Reason
- Presence of Particulate Matter: particulate matter was found during the manufacturing process.
- Published
- October 8, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
- Reason
- Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.
- Published
- October 8, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29
- Reason
- Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
- Published
- October 8, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
- Reason
- Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
- Published
- October 8, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03
- Reason
- Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
- Published
- October 1, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3.
- Reason
- Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
- Published
- October 1, 2014
- 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.
