PlainRecalls

Product category · Updated Aug 19, 2026

Drugs & Medications recalls

Prescription and over-the-counter medication recalls

Total recalls
14,473
Top agency
FDA Drug
Years covered
2004–2026
Check a product → All categories

Drugs & Medications ranks #3 of 12 among PlainRecalls categories by recall count (14,473 notices, 13.9% of the archive); 10% of graded records are high-severity.

The FDA, CPSC, USDA FSIS and NHTSA have published 14,473 drugs & medications recalls between 2004 and 2026 - roughly 13.9% of the 104,423-record archive. Among 12 product categories, that is #3 of 12. Of the 14,473 records graded for severity, 10% are high-severity. Most are issued by FDA Drug. Counts reflect market size and reporting activity, not a product's inherent danger.

  • 14,473 total recalls
  • #3 of 12 among categories
  • 10% graded high-severity
  • FDA Drug top agency

Category snapshot

According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Drugs & Medications is #3 of 12 (3rd of 12) with 14,473 recalls, about 13.9% of the 104,423-record federal archive, with 1,508 graded high-severity, most issued by FDA Drug.

14,473
total recalls
#3 of 12
category rank by events
10%
graded high-severity
FDA Drug
top issuing agency

Where Drugs & Medications sits among all 12 categories

Distinct recall-event inventory across every PlainRecalls product category. Drugs & Medications is marked; archive size reflects reporting volume, not inherent product danger.

Drugs & Medications vs all categories by recall count

Where this category's archive sits among every tracked product class

14,473 3rd of 12 higher than 9 of 12 categories

Categories, banded by distinct recall-event inventory

Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-27

Do more recalls mean more Class I danger?

Drugs & Medications sits at the 71st percentile of category volume (14,473 recalls) and the 29th percentile of Class I rate (10.5% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.

Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-09-27. 2×2 strategic matrix plotting 7 entities by Total recalls (count) (X) and Class I share of classified (%) (Y), with a crosshair dividing the plot into four quadrants. Large · Class I–heavySmaller · Class I–heavyLarge · fewer Class ISmaller · fewer Class I 010,00020,00030,00040,00050,000 0%20%40%60%80% Total recalls (count) Class I share of classified (%) Category volume vs Class I rate Signature insight Medical DevicesFoodDrugs & MedicationsChildren & Baby ProductsDietary SupplementsMeat & PoultryCosmetics & Personal Care
Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-09-27.
Read the chart, every category as text

Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.

CategoryRecallsVol %ileClassifiedClass IClass I %Rate %ile
Medical Devices41,07010040,7633,6539%14
Food25,5138625,22211,67646.3%86
Drugs & Medications14,4737114,4171,50810.5%29
Children & Baby Products4,017572,48335214.2%43
Dietary Supplements2,018431,99346623.4%71
Meat & Poultry1,672291,6721,14568.5%100
Cosmetics & Personal Care1,388141,28920315.7%57

Drugs & Medications recalls by year

2004–2026

0 300 600 900 1200 1500 1800 2100 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 1843 887 925 1233 1617 638 859 1103 985 516 563 448

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Recalls in Drugs & Medications

Newest first · Page 113 of 290

FDA Drug Moderate Oct 9, 2019

Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674047

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678362

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678320

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677379

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.

Akorn, Inc.

FDA Drug Moderate Oct 9, 2019

C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Vial) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678398

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678092

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673974

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678355

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674166

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678406

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674232

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677510

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321673964

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678416

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Critical Oct 2, 2019

Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02

Shire Human Genetic Therapies, Inc.

FDA Drug Critical Oct 2, 2019

Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02

Shire Human Genetic Therapies, Inc.

FDA Drug Low Oct 2, 2019

minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI Health, LLC 134 Columbus St. Charleston, SC 29403 USA. NDC 71403-102-05.

EPI Health, LLC

FDA Drug Moderate Oct 2, 2019

Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30

Akorn, Inc.

FDA Drug Moderate Oct 2, 2019

Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001.

Johnson Matthey Inc.

FDA Drug Moderate Oct 2, 2019

Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09

Preferred Pharmaceuticals, Inc

FDA Drug Moderate Oct 2, 2019

Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001

Johnson Matthey Inc.

FDA Drug Moderate Oct 2, 2019

Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX

Johnson Matthey Inc.

FDA Drug Critical Oct 2, 2019

Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02

Shire Human Genetic Therapies, Inc.

FDA Drug Critical Oct 2, 2019

Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02

Shire Human Genetic Therapies, Inc.

FDA Drug Critical Oct 2, 2019

Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707

Darmerica, LLC

FDA Drug Moderate Oct 2, 2019

Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0892-42.

Cardinal Health dba Specialty Pharmaceutical Services

FDA Drug Moderate Sep 25, 2019

PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-15), and c) 4 Oz (NDC 69804-019-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

Ridge Properties, LLC

FDA Drug Moderate Sep 25, 2019

Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-073-14), b) 2 Oz (NDC 69804-073-15), and c) 4 Oz (NDC 69804-073-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

Ridge Properties, LLC

FDA Drug Moderate Sep 25, 2019

Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104.

Aurolife Pharma, LLC

FDA Drug Moderate Sep 25, 2019

Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55.

Aurolife Pharma, LLC

What to do with this

Monitoring drugs & medications? Start here.

  • Check a specific product against the full federal archive before you use or buy it. Recall checker
  • Most drugs & medications recalls come from FDA Drug - browse that agency's full feed. FDA Drug recalls
  • Sort the whole archive by severity to see the highest-risk active recalls first. Rankings

Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.

Nearby categories

Adjacent product categories that share hazard patterns or regulatory oversight.

Data sources

Category data as of Aug 19, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Category counts and the year trend are computed across the full archive for drugs & medications. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Aug 19, 2026.