FDA Recall Terminated Historical recordClass II
Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
- Reason
- CGMP Deviations
- Published
- July 18, 2018
- Distribution
- Nationwide
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Recall totals
All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.
37,139
Total recall recordsAll FDA and USDA recalls in Public Health Trace9,799
Class I recallsReasonable probability of serious health consequences24,349
Class II recallsTemporary or medically reversible health consequences2,891
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
Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/deanos-pasta-issue-allergy-alert-undeclared-lobster-pear-and-pecorino-triangoli-ravioliPublished September 24, 2026
Download matching recalls as CSV
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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 | 24,349 |
| Class I | 9,799 |
| Class III | 2,891 |
| Not Yet Classified | 1 |
| Class | Recalls |
|---|---|
| Class II | 24,349 |
| Class I | 9,799 |
| Class III | 2,891 |
| Not Yet Classified | 1 |
FDA Recall Terminated Historical recordClass III
Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 18, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 18, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
- Reason
- Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
- Published
- July 18, 2018
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass I
Pinnacle Food Group, Llc
- Product
- Wish Bone House Italian Salad Dressing 15 oz.
- Reason
- The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg not declared on the bottle.
- Published
- July 18, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01.
- Reason
- Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
- Published
- July 11, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02.
- Reason
- Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
- Published
- July 11, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716
- Reason
- Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
- Published
- July 11, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date.
- Published
- July 11, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date.
- Published
- July 11, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.
- Reason
- Superpotent Drug: High out of specification assay value results for potency.
- Published
- July 11, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.
- Reason
- Superpotent Drug: High out of specification assay value results for potency.
- Published
- July 11, 2018
- Distribution
- Nationwide
FDA Recall United States Ongoing Historical recordClass III
Absonutrix
- Product
- Lyfetrition Live Life Nutritiously Vitamin B12 2 FL. OZ bott…
- Reason
- The firm was informed that the product did not contain vitamin B12 (Methylcobalamyn) as listed on the label.
- Published
- July 4, 2018
- Distribution
- Product was shipped to the following sta…
FDA Recall Terminated Historical recordClass III
Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 27, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 27, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 27, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
- Reason
- Lack of assurance of sterility: Bags have potential to leak.
- Published
- June 27, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
- Reason
- Lack of assurance of sterility: Bags have potential to leak.
- Published
- June 27, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
- Reason
- Lack of assurance of sterility: Bags have potential to leak.
- Published
- June 27, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
- Reason
- Lack of assurance of sterility: Bags have potential to leak.
- Published
- June 27, 2018
- 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.
