Top 20 Reasons For Drug Recalls in USA - Review of 2018 Data

Drug Recall Trend 2018

The effect of drug recalls is huge on the pharma companies as well as patients. The 'drug recall' weakens the company economically and leads to regulatory actions and at the same time the drug shortage, due to recall, affects the patients' health. So, it's necessary to review the trend of recalls to understand what type of issues are leading to drug recalls.

To fulfil my curiosity, I have reviewed the US drug recalls trend of 2018. I have taken a drug recall initiation date as a base for obtaining the figures and analyze the things. The source for this data is the US FDA's web page Enforcement Report.

This review of data covers only drugs and not included biologics, cosmetics, devices and veterinary.

For our easy understanding, I have divided the recalls into 20 categories/reasons and prepared the statistics. Let us go through the details. The total drug recalls in 2018 are 702 and arrived at this figure based on recall initiation date. Whatever may be the figures, understanding of the issues is very important. I hope this data will help you.

Statistics of Drug Recalls - Year 2018

Total Recalls : 702
Recalls # Recalls
Voluntary: FDA Requested 4
Voluntary: Firm Initiated 698

Classification of Recalls
Recall Type # Recalls
Class I 89
Class II 613
Class III 0

Recalls Month Wise
Month # Recalls
January 50
February 86
March 74
April 113
May 76
June 96
July 75
August 115
September 1
October 5
November 4
December 7
Recalls Country Wise
Country # Recalls
Canada 3
China 2
India 10
United States 687

Recalls Communication to Public
Communication # Recalls
E-Mail 17
Letter 581
Press Release 81
Telephone 6
Two or more of the following:
Email, Fax, Letter, Press Release, Telephone, Visit

Top 20 Categories for Drug Recalls - Year 2018

Sr. No. Category # Recalls
1 Violation of cGMP 238
2 Lack of sterility assurance 171
3 Lack of processing controls 79
4 Microbial contamination of non-sterile product 49
5 Out of Specification (OOS) 26
6 Marketed without an approved NDA/ANDA 25
7 Labeling issues 24
8 Presence of particulate matter 22
9 Subpotent drug 13
10 Defective delivery System 12
11 Non-sterility 8
12 Superpotent Drug 8
13 Presence of foreign substance 6
14 Stability data does not support expiry 6
15 Defective container 4
16 Presence of foreign Tablets/Capsules 4
17 Temperature abuse 3
18 Incorrect product formulation 2
19 Presence of precipitate 1
20 Product mix-Up 1

Now let us look into the issues found by the US FDA in each category.

1. Issues Found Related To Violation of cGMP

Sr. No. Recall Type Issue
1 Class II Lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
2 Class II Complaints of odor related to CGMP deficiencies.
3 Class II Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
4 Class II The product was produced with substandard GMP manufacturing processes.
5 Class II Finished products were manufactured with poor quality water
6 Class II Cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
7 Class II Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
8 Class II A recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
9 Class II Out of specification total aerobic microbial count in a water sample.
10 Class II Products may be contaminated with bacteria.
11 Class II Products not manufactured under current good manufacturing practices.
12 Class II Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
13 Class II Carcinogen impurity detected in API used to manufacture drug product.
14 Class II Product was released while a hood certification discrepancy was being investigated.
15 Class II Products manufactured under conditions that could impact its product quality.
16 Class I Contraceptive Tablets Out of Sequence.

2. Issues Found Related To Lack of Sterility Assurance

Sr. No. Recall Type Issue
1 Class I Product was found to contain undeclared colloidal silver.
2 Class II Failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
3 Class II Firm used a non-approved method of sterilization.
4 Class II Leaking bags and mold found between the outer bag and the overwrap.
5 Class II Airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
6 Class II Bags have potential to leak.
7 Class II Practices at firm may call into question the sterility of products intended to be sterile.

3. Issues Found Related To Lack of Processing Controls

Sr. No. Recall Type Issue
1 Class II Lack of adequate controls during manufacturing.
2 Class II Products produced in a manner that calls into question the sterility of the drug product intended to be sterile.

4. Issues Found Related To Microbial Contamination of Non-Sterile Product

Sr. No. Recall Type Issue
1 Class I FDA analysis found salmonella contamination.
2 Class I Potential of high microbial loads.
3 Class I Product failed microbiological testing for Pseudomonas aeruginosa.
4 Class I Out of specification microbial results.
5 Class I Products contaminated with microorganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia.
6 Class II Product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
7 Class II FDA analysis returned out of specification results for total aerobic microbial counts.
8 Class II Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
9 Class II Sample tested positive for Staphylococcus aureus.
10 Class II Failed microbiological testing for Staphalococcus aureus.
11 Class II Failure for microbiological growth exceeding specification.

5. Issues Found Related To Out of Specification (OOS)

Sr. No. Recall Type Issue
1 Class I Failed Content Uniformity Specifications
2 Class II Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
3 Class II Failed Stability Specifications.
4 Class II Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
5 Class II Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity.
6 Class II Out-of-specification (OOS) test results for below assay and above specification for degradants.
7 Class II Failed Tablet/Capsule Specifications: Tablet breakage.
8 Class II Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
9 Class II Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
10 Class II Out of specification (OOS) results for unspecified impurity.

6. Issues Found Related To Marketed Without An Approved NDA/ANDA

Sr. No. Recall Type Issue
1 Class I Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
2 Class I The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
3 Class I FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
4 Class I Product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.
5 Class I FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
6 Class I It was found in the FDA analysis that presence of sildenafil and tadalafil makes the products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
7 Class II Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
8 Class II 2-pack configuration did not receive appropriate regulatory approval prior to release.
9 Class II API material used in the manufacturing of the product did not receive regulatory approval prior to release.

7. Issues Found Related To Labeling

Sr. No. Recall Type Issue
1 Class I LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
2 Class I Bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.
3 Class I Label Mix-Up: the ingredients on the front sticker may not match the actual product in the carton.
4 Class I 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.
5 Class I Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
6 Class I Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
7 Class I Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
8 Class I An incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex.
9 Class I Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
10 Class II Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
11 Class I The product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex .
12 Class II A labeled declaration of "store at temperature" differs from the original manufacturer declaration.
13 Class II Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
14 Class II Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.

8. Issues Found Related To Presence of Particulate Matter

Sr. No. Recall Type Issue
1 Class I Presence of visible particulate matter, confirmed as glass, within a single vial.
2 Class I Product contains visible particulate matter identified as mold.
3 Class I Presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
4 Class I Potential for particulate matter on the syringe plunger.
5 Class I Presence of particulate matter which identified as glass and silicone material
6 Class I Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
7 Class II Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
8 Class II Presence of unknown particulate matter.
9 Class II Organic and inorganic compounds detected in vials of product.

9. Issues Found Related To Subpotent Drug

Sr. No. Recall Type Issue
1 Class I High Levels of Impurities Resulting in Decrease Potency.
2 Class I Product may not have the active ingredient present in the bag.
3 Class II Product not meeting the iodine assay level requirements through the labeled expiry.
4 Class II Final drug concentration is subpotent as compared to the concentration indicated on the label.
5 Class II Drug and Failed Content Uniformity.
6 Class II Stability data does not support the current expiration dating of 55 days after compounding.
7 Class II Low out of specification assay results for the bacitracin zinc ingredient.

10. Issues Found Related To Defective Delivery System

Sr. No. Recall Type Issue
1 Class II Out of specification for adhesive transfer.
2 Class II No longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches.
3 Class II There is a potential for some tablets to be missing the laser drilling which might affect drug release.

11. Issues Found Related To Non-sterility

Sr. No. Recall Type Issue
1 Class I Confirmed customer complaints of glass product container vials that may be empty or cracked.
2 Class I Product manufactured under non-sterile production conditions.
3 Class II Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

12. Issues Found Related To Superpotent Drug

Sr. No. Recall Type Issue
1 Class II Over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
2 Class II High out of specification assay value results for potency.
3 Class II High out of specification assay results for the camphor ingredient.
3 Class II High out of specification assay results for the menthol ingredient.

13. Issues Found Related To Presence of Foreign Substance

Sr. No. Recall Type Issue
1 Class II Potential for glass in the neck area of the glass bottles.
2 Class II A foreign matter identified as polyethylene was detected in two (2) tablets.
3 Class II Presence of glass particles.
4 Class II A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
5 Class II One lot for Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
6 Class II Product complaint was received of metal contaminant observed in one tablet.

14. Issues Found Related To Stability Data Does Not Support Expiry

Sr. No. Recall Type Issue
1 Class II 90-day beyond use date (BUD) for the affected product is not supported.
2 Class II Stability data from manufacturer does not support expiration dates listed.

15. Issues Found Related To Defective Container

Sr. No. Recall Type Issue
1 Class II Loose vial crimps.
2 Class II Cracked glass at the rim surface of glass vials.
3 Class II Difficulty in dispensing the tablet from the applicator.
4 Class II Tamper Evident foil seal not completely intact.

16. Issues Found Related To Presence of Foreign Tablets/Capsules

Sr. No. Recall Type Issue
1 Class II Bottles could contain both Pravastatin Sodium 10 mg and 20 mg tablets in the same bottle.
2 Class II Cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
3 Class II One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.

17. Issues Found Related To Temperature Abuse

Sr. No. Recall Type Issue
1 Class II Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
2 Class II Product samples of Admelog may not have been shipped at proper temperature.

18. Issues Found Related To Incorrect Product Formulation

Sr. No. Recall Type Issue
1 Class II Wrong sunscreen product in the package.

19. Issues Found Related To Presence of Precipitate

Sr. No. Recall Type Issue
1 Class I Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.

20. Issues Found Related To Product Mix-Up

Sr. No. Recall Type Issue
1 Class I Customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.


The above data reveal us that labelling Issue, lack of Processing Controls, lack of Sterility Assurance, drugs entry into market without an Approved NDA/ANDA, Microbial Contamination, Out of Specification (OOS), Presence of Particulate Matter and violation of cGMP is the top major reasons, among the total 20 reasons, for drug recalls in the USA.

This data indicates the poor control of manufacturing activities in pharmaceutical companies.

The number of drug recalls due to cGMP is very high and occupying the first place in the list. This means that the cGMP regulation is not being implemented in its fullest meaning at the manufacturing sites. This is an alarming situation and gives scope for the entry of adulterated drugs into the market.

SHARE this article with your friends, if you feel this is helpful. It may help them if they are in need. Each one help one.

Author Profile


Ram Kumar Reddy

Ram Kumar Reddy is the founder of Pharma Times Now. Helping Pharmacy and Chemistry students, along with the pharma employees, in learning pharmaceutical science. He has 24 years of rich experience in the Pharmaceutical industry and well versed in quality systems. He worked with Dr.Reddys and Sai Life Sciences. He lives in Hyderabad, India.

No comments