Product category · Updated Aug 19, 2026

Drugs & Medications recalls

Name: Drugs & Medications Recalls
Creator: PlainRecalls
License: https://creativecommons.org/publicdomain/zero/1.0/

Prescription and over-the-counter medication recalls

Total recalls: 14,473
Top agency: FDA Drug
Years covered: 2004–2026

Compiled from official public sources by the publisher. · Updated September 2026

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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 · 2026-09-29

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 2026-09-29.

Read the chart, every category as text

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

Category	Recalls	Vol %ile	Classified	Class I	Class I %	Rate %ile
Medical Devices	41,070	100	40,763	3,653	9%	14
Food	25,513	86	25,222	11,676	46.3%	86
Drugs & Medications	14,473	71	14,417	1,508	10.5%	29
Children & Baby Products	4,017	57	2,483	352	14.2%	43
Dietary Supplements	2,018	43	1,993	466	23.4%	71
Meat & Poultry	1,672	29	1,672	1,145	68.5%	100
Cosmetics & Personal Care	1,388	14	1,289	203	15.7%	57

High severity

1,508
Moderate

11,608
Lower severity

1,357

FDA Drug

14,105
FDA Food

312
CPSC

56

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 148 of 290

FDA Drug Moderate May 16, 2018

Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.

Vitalab Pharmacy, Inc

FDA Drug Moderate May 16, 2018

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01

Dr. Reddy's Laboratories, Inc.

FDA Drug Moderate May 16, 2018

Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc

Vitalab Pharmacy, Inc

FDA Drug Moderate May 16, 2018

Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply

Kroger Specialty Pharmacy, Inc.

FDA Drug Moderate May 16, 2018

Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply

Kroger Specialty Pharmacy, Inc.

FDA Drug Low May 16, 2018

OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10

Septodont Inc.

FDA Drug Critical May 16, 2018

Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.

AuroMedics Pharma LLC

FDA Drug Moderate May 16, 2018

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

Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
Source: CPSC - Consumer Product Safety Commission Recalls
Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)

Category data as of Aug 19, 2026.

Compiled by PlainRecalls, Product Recalls Editorial Process · September 29, 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.

Where Drugs & Medications sits among all 12 categories

Do more recalls mean more Class I danger?

Recalls in Drugs & Medications

Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply

Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply

Otezla 30 mg tablet NDC 59572-0631-06 30 days supply;

Altera Handset NDC 83490-0678-05 56 days supply

Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply

Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01

Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.

Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply

Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply

Xolair 150 mg SDV NDC 50242-0040-62 28 days

Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply

Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply

Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply

Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply

Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply

Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply

Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04

Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply.

Botox 100 Units Vial NDC 00023-1145-01 90 days supply.

Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply

Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc

Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply

Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply.

Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.

Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc

Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply

OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply

Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply.

Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply.

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01

Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply

Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply

Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply

Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply

Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply

Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply

Ibrance 125 mg cap NDC 00069-0189-21 28 days supply

Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply

Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc

Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply

Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc

Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply

Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply

OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10

Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.

Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.

Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply

Temozolomide 250 mg NDC 43975-0257-05 28 days supply

Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply

Promacta 50 mg tablet NDC 00078-0686-15 30 days supply

Nearby categories

Medical Devices

Food

Vehicles

Children & Baby Products

Household Products

Dietary Supplements

Data sources