Product category · Updated Jun 3, 2026
Drugs & Medications recalls
Prescription and over-the-counter medication recalls
Drugs & Medications accounts for 14,290 recalls, about 14.1% of the federal recall archive, of which 10% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 14,290 drugs & medications recalls between 2000 and 2026 - roughly 14.1% of the 101,704-record archive. Of the 14,290 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.
- 14,290 total recalls
- 14.1% of the archive
- 10% graded high-severity
- FDA Drug top agency
Category snapshot
Drugs & Medications accounts for 14,290 recalls, about 14.1% of the 101,704-record federal archive, with 1,496 graded high-severity, most issued by FDA Drug.
- 14,290
- total recalls
- 10%
- graded high-severity
- FDA Drug
- top issuing agency
- 2000–2026
- years covered
Drugs & Medications recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 1,496
High severity
1,496 recalls
- Moderate
Moderate
11,448 recalls
- Lower severity 1,346
Lower severity
1,346 recalls
Recalls by issuing agency
- FDA Drug
FDA Drug
13,922 recalls
- FDA Food 310
FDA Food
310 recalls
- CPSC 58
CPSC
58 recalls
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 35 of 286
FDA Drug Moderate Jun 7, 2023
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurn…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL …
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, …
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, I…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., …
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. AL…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurne…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY …
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: A…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operat…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031.…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution,…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake F…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 1…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn Operating Com…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL N…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manuf…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 6…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. …
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- Lake Forest…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distribu…
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, …
Akorn, Inc.
FDA Drug Moderate Jun 7, 2023
Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Akorn, Inc.
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
- 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 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.