PlainRecalls

Product category · Updated Jun 3, 2026

Drugs & Medications recalls

Prescription and over-the-counter medication recalls

Total recalls
14,058
Top agency
FDA Drug
Years covered
2000–2026
Compiled from official public sources by the editorial team.
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Drugs & Medications accounts for 14,058 recalls — about 14.0% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 14,058 drugs & medications recalls between 2000 and 2026 — roughly 14.0% of the 100,165-record archive. Of the 14,058 records graded for severity, 9% are high-severity. Most are issued by FDA Drug. Counts reflect market size and reporting activity, not a product's inherent danger.

  • 14,058 total recalls
  • 14.0% of the archive
  • 9% graded high-severity
  • FDA Drug top agency

Category snapshot

Drugs & Medications accounts for 14,058 recalls, about 14.0% of the 100,165-record federal archive, with 1,277 graded high-severity, most issued by FDA Drug.

14,058
total recalls
9%
graded high-severity
FDA Drug
top issuing agency
2000–2026
years covered

Drugs & Medications recalls by year

2000–2026

0 300 600 900 1200 1500 1800 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 1797 1025 953 1253 1406 756 706 1080 904 555 658 216

Source: FDA · CPSC · NHTSA As of Jun 3, 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 126 of 282

FDA Drug Moderate Jan 23, 2019

Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810…

Aurobindo Pharma USA Inc.

FDA Drug Moderate Jan 23, 2019

Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 6586…

Aurobindo Pharma USA Inc.

FDA Drug Moderate Jan 23, 2019

Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810…

Aurobindo Pharma USA Inc.

FDA Drug Moderate Jan 23, 2019

Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810…

Aurobindo Pharma USA Inc.

FDA Drug Moderate Jan 23, 2019

Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 658…

Aurobindo Pharma USA Inc.

FDA Drug Moderate Jan 23, 2019

Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810…

Aurobindo Pharma USA Inc.

FDA Drug Moderate Jan 23, 2019

Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 658…

Aurobindo Pharma USA Inc.

FDA Drug Moderate Jan 23, 2019

Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manu…

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Jan 16, 2019

Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pha…

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Jan 16, 2019

Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured b…

Glenmark Pharmaceuticals Inc., USA

FDA Drug Moderate Jan 16, 2019

Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : …

Heritage Pharmaceuticals, Inc.

FDA Drug Moderate Jan 16, 2019

Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pha…

Lupin Pharmaceuticals Inc.

FDA Drug Critical Jan 16, 2019

Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); R…

Lupin Pharmaceuticals Inc.

FDA Drug Critical Jan 16, 2019

Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceuti…

Sun Pharmaceutical Industries, Inc.

FDA Drug Critical Jan 16, 2019

Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); R…

Lupin Pharmaceuticals Inc.

FDA Drug Critical Jan 16, 2019

Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx o…

Lupin Pharmaceuticals Inc.

FDA Drug Critical Jan 16, 2019

Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc…

Lupin Pharmaceuticals Inc.

FDA Drug Critical Jan 16, 2019

Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun Pharmaceutic…

Sun Pharmaceutical Industries, Inc.

FDA Drug Moderate Jan 9, 2019

Lidocaine gel 2%, RX, plastic dropper

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

FDA Drug Moderate Jan 9, 2019

Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

FDA Drug Moderate Jan 9, 2019

Glutathione liquid, 200mg/ml, Rx

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

FDA Drug Moderate Jan 9, 2019

Lidocaine gel 1%, RX, plastic dropper

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

FDA Drug Moderate Jan 9, 2019

HCG liquid, 1000u/ml, RX, glass vial, various

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

FDA Drug Moderate Jan 9, 2019

Testosteron Cypionate liquid 200mg/ml, RX, glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

FDA Drug Moderate Jan 9, 2019

Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured f…

LUPIN SOMERSET

FDA Drug Moderate Jan 9, 2019

Glutathione liquid, 100mg/ml

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

FDA Drug Moderate Jan 9, 2019

Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

FDA Drug Moderate Jan 9, 2019

Epinephrine liquid 1:1000, RX, glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

FDA Drug Critical Jan 2, 2019

Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe…

Advanced Pharma Inc.

FDA Drug Low Jan 2, 2019

Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmac…

Amerigen Pharmaceuticals Inc.

FDA Drug Low Jan 2, 2019

Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharma…

Amerigen Pharmaceuticals Inc.

FDA Drug Moderate Dec 26, 2018

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distribu…

Tris Pharma Inc.

FDA Drug Critical Dec 26, 2018

Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01

Asclemed USA Inc. dba Enovachem

FDA Drug Moderate Dec 26, 2018

Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intra…

Pharmedium Services, LLC

FDA Drug Low Dec 26, 2018

Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.

CBI Laboratories, Inc.

FDA Drug Moderate Dec 26, 2018

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bo…

Tris Pharma Inc.

FDA Drug Moderate Dec 26, 2018

Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10

Pharm D Solutions, LLC

FDA Drug Moderate Dec 26, 2018

Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-…

Pfizer Inc.

FDA Drug Moderate Dec 26, 2018

Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE Healthcare Inc.…

GE Healthcare Inc. Life Sciences

FDA Drug Critical Dec 26, 2018

Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01

Asclemed USA Inc. dba Enovachem

FDA Drug Low Dec 26, 2018

Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. H…

Sun Pharmaceutical Industries, Inc.

FDA Drug Moderate Dec 26, 2018

Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01

Epic Pharma, LLC

FDA Drug Moderate Dec 26, 2018

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) b…

Tris Pharma Inc.

FDA Drug Moderate Dec 26, 2018

Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50

KVK-Tech, Inc.

FDA Drug Moderate Dec 26, 2018

Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc.…

Cipla Limited

FDA Drug Moderate Dec 26, 2018

Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syrin…

Pharmedium Services, LLC

FDA Drug Low Dec 26, 2018

NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per ca…

VistaPharm, Inc.

FDA Drug Low Dec 26, 2018

Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort W…

CBI Laboratories, Inc.

FDA Drug Low Dec 26, 2018

Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430…

Glenmark Pharmaceuticals Inc., USA

FDA Drug Moderate Dec 26, 2018

Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories,…

Gordon Laboratories

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 Jun 3, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC 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 Jun 3, 2026.