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 · 2026-09-28

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 2026-09-28. 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 2026-09-28.
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 119 of 290

FDA Drug Moderate Jun 19, 2019

Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6479-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.

Torrent Pharma Inc

FDA Drug Moderate Jun 19, 2019

Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.

Synthetopes Inc

FDA Drug Moderate Jun 19, 2019

Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored, a) 4 Fl. oz. bottle, NDC: 0536-0122-97, b) One Pint (473 mL) bottle, NDC: 0536-0122-85, Distributed by Rugby Laboratories, Lavonia, MI 48152 USA.

Torrent Pharma Inc

FDA Drug Moderate Jun 19, 2019

Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin Pharma, Skokie, IL 60076.

Torrent Pharma Inc

FDA Drug Moderate Jun 19, 2019

Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.

Synthetopes Inc

FDA Drug Moderate Jun 19, 2019

Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663

Torrent Pharma Inc

FDA Drug Moderate Jun 19, 2019

Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz., NDC: 13668-580-12, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.

Torrent Pharma Inc

FDA Drug Moderate Jun 19, 2019

Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71

Glenmark Pharmaceuticals Inc., USA

FDA Drug Low Jun 19, 2019

Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.

Bausch & Lomb

FDA Drug Moderate Jun 19, 2019

Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

Pharm D Solutions, LLC

FDA Drug Moderate Jun 19, 2019

Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

Pharm D Solutions, LLC

FDA Drug Moderate Jun 19, 2019

Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.

Synthetopes Inc

FDA Drug Moderate Jun 19, 2019

Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..

Torrent Pharma Inc

FDA Drug Moderate Jun 19, 2019

Bisacodyl Suppositories, Brite Stock, Reese.

Torrent Pharma Inc

FDA Drug Moderate Jun 19, 2019

Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

Pharm D Solutions, LLC

FDA Drug Moderate Jun 19, 2019

Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

Pharm D Solutions, LLC

FDA Drug Moderate Jun 19, 2019

Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

Pharm D Solutions, LLC

FDA Drug Moderate Jun 19, 2019

Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

Pharm D Solutions, LLC

FDA Drug Moderate Jun 19, 2019

Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08

Geritrex, LLC

FDA Drug Moderate Jun 19, 2019

B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1611-30

Pharm D Solutions, LLC

FDA Drug Moderate Jun 19, 2019

Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD

Torrent Pharma Inc

FDA Drug Moderate Jun 19, 2019

Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64

Baxter Healthcare Corporation

FDA Drug Moderate Jun 19, 2019

Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

Pharm D Solutions, LLC

FDA Drug Moderate Jun 19, 2019

Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) bottle., NDC: 0536-0770-85, Distributed by Rugby Laboratories, Livonia, MI 48152.

Torrent Pharma Inc

FDA Drug Moderate Jun 19, 2019

Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.

Synthetopes Inc

FDA Drug Moderate Jun 19, 2019

ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.

Chiesi USA, Inc.

FDA Drug Moderate Jun 19, 2019

Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

Pharm D Solutions, LLC

FDA Drug Moderate Jun 19, 2019

Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle, NDC:16571-330-16, Manufactured by Bio-Pharm Inc., Levittown, PA 10957, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663.

Torrent Pharma Inc

FDA Drug Critical Jun 19, 2019

PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31

Heritage Pharmaceuticals, Inc.

FDA Drug Low Jun 19, 2019

Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20

Fresenius Kabi USA, LLC

FDA Drug Moderate Jun 19, 2019

Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

Pharm D Solutions, LLC

FDA Drug Moderate Jun 19, 2019

Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant, nasal decongestant, Chlorpheniramine Maleate, USP 2 mg; Dextromethorphan HBr, USP 10 mg; Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10 mL)), 4 Fl. oz. (118 mL) bottle, NDC:0904-5050-20, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Torrent Pharma Inc

FDA Drug Moderate Jun 19, 2019

Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.

Synthetopes Inc

FDA Drug Moderate Jun 19, 2019

Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC: 0904-5058-12, b) 100 suppositories per carton, NDC: 0904-5058-60, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.

Torrent Pharma Inc

FDA Drug Critical Jun 5, 2019

The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.

Stiff Boy LLC

FDA Drug Moderate Jun 5, 2019

Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401 North 10th Street, Philadelphia, PA 19123.

Inopak Ltd

FDA Drug Moderate Jun 5, 2019

Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD

Inopak Ltd

FDA Drug Moderate Jun 5, 2019

AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris Pharmaceuticals (Division of Inopak).

Inopak Ltd

FDA Drug Moderate May 29, 2019

Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-09

Heritage Pharmaceuticals, Inc.

FDA Drug Moderate May 29, 2019

Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-09

Heritage Pharmaceuticals, Inc.

FDA Drug Moderate May 29, 2019

Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-644-09

Heritage Pharmaceuticals, Inc.

FDA Drug Moderate May 29, 2019

Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-10

Heritage Pharmaceuticals, Inc.

FDA Drug Moderate May 29, 2019

Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-601-16 Reorder #: 51116

Septodont Inc.

FDA Drug Moderate May 29, 2019

Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-10

Heritage Pharmaceuticals, Inc.

FDA Drug Critical May 29, 2019

Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ireland, NDC 0078-0972-61.

Novartis Pharmaceuticals Corp.

FDA Food Low May 22, 2019

Item #13898 Raw California Orange Blossom Honey, packaged in an 18 oz jar with gold metal lid. Retail Jar UPC: 0 30042 00305 9. Item #13899 Raw California Orange Blossom Honey packaged in a case with 6 / 18 oz jars with gold metal lids. Case UPC: 0 30042 00338 7. The label is read in parts: "*** Raw Honey California ORANGE BLOSSOM*** Ingredients: 100% Pure Honey *** Product of USA***".

Glorybee Natural Sweeteners, Inc.

FDA Drug Moderate May 22, 2019

DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL), Cherry Flavor, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-011-20, UPC 370302223019

Unipharma, Llc.

FDA Drug Moderate May 22, 2019

CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01, UPC 050428598368

Unipharma, Llc.

FDA Drug Moderate May 22, 2019

CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor 20 Single-Use Vials per carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-0258-01, UPC 050428601891

Unipharma, Llc.

FDA Drug Moderate May 22, 2019

DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, 0.17 fl. oz. (5 mL), Mixed Berry, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-012-20, UPC 370302255010

Unipharma, 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.