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 · 2026-09-24

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 2026-09-24. 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 2026-09-24.
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 77 of 290

FDA Drug Moderate Nov 17, 2021

Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Moderate Nov 17, 2021

ALPROSTADIL 25MCG/ML 25MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

FDA Drug Moderate Nov 17, 2021

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

FDA Drug Moderate Nov 10, 2021

Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Nov 10, 2021

Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Nov 10, 2021

Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Nov 10, 2021

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA

Dr. Reddy's Laboratories, Inc.

FDA Drug Moderate Nov 10, 2021

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA

Dr. Reddy's Laboratories, Inc.

FDA Drug Moderate Nov 10, 2021

Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Nov 10, 2021

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA

Dr. Reddy's Laboratories, Inc.

FDA Drug Moderate Nov 10, 2021

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA, , packaged in bottles.

Dr. Reddy's Laboratories, Inc.

FDA Drug Critical Nov 10, 2021

Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01

MERCK SHARP & DOHME CORP

FDA Drug Critical Nov 10, 2021

Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

FDA Drug Moderate Nov 10, 2021

Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only

Lupin Pharmaceuticals Inc.

FDA Drug Low Nov 3, 2021

Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA

MACLEODS PHARMA USA, INC

FDA Drug Moderate Nov 3, 2021

PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41

MACLEODS PHARMA USA, INC

FDA Drug Low Nov 3, 2021

Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)

Ultra Seal Corporation

FDA Drug Moderate Nov 3, 2021

METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)

Ultra Seal Corporation

FDA Drug Low Nov 3, 2021

AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Moderate Nov 3, 2021

ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Nov 3, 2021

ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41

MACLEODS PHARMA USA, INC

FDA Drug Moderate Nov 3, 2021

TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)

Ultra Seal Corporation

FDA Drug Moderate Nov 3, 2021

MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)

Ultra Seal Corporation

FDA Drug Low Nov 3, 2021

AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )

Ultra Seal Corporation

FDA Drug Moderate Nov 3, 2021

TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917

Ultra Seal Corporation

FDA Drug Moderate Nov 3, 2021

VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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.