Drug Recalls

Drug Recall Results

Hospira – Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units

Date: 05/22/2024
Company: Hospira Inc.
Dosage Form: Injection
Recall Issue Type: Labeling / Packaging
Recall Reason: Device & Drug Safety – Potential Packaging Defect

Schwinnng – Herbal Dietary Supplement

Date: 04/23/2024
Company: STOP CLOPEZ CORP
Dosage Form: Other / Unspecified
Recall Issue Type: Other Recall Issue
Recall Reason: Product is tainted with Nortadalafil

Dr. Reddy’s – Sapropterin Dihydrochloride Powder for Oral Solution 100 mg

Date: 04/23/2024
Company: Dr. Reddy’s Laboratories Inc
Dosage Form: Solution, Powder
Recall Issue Type: Other Recall Issue
Recall Reason: Decreased Potency

Fendall 2000 – Non-Sterile Eyewash Cartridge

Date: 04/05/2024
Company: Honeywell Safety Products USA
Dosage Form: Other / Unspecified
Recall Issue Type: Quality / Potency
Recall Reason: Non-compliance with current good manufacturing practice (cGMP) requirements.

AVpak – Atovaquone Oral Suspension, USP 750mg/5mL

Date: 04/01/2024
Company: AvKARE, LLC
Dosage Form: Suspension
Recall Issue Type: Contamination / Sterility
Recall Reason: Potential Bacillus cereus contamination

Eugia US LLC – Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial)

Date: 03/28/2024
Company: Eugia US LLC
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Device & Drug Safety – Presence of Particulate Matter

Amneal – Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL

Date: 03/27/2024
Company: Amneal Pharmaceuticals, LLC.
Dosage Form: Solution
Recall Issue Type: Other Recall Issue
Recall Reason: Super potent due to bottles being overfilled

Various – Dietary supplements for sexual enhancement

Date: 03/20/2024
Company: Pyramid Wholesale
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Sildenafil and/or Tadalafil

Par Pharmaceutical – Treprostinil 20mg/20mL Injection

Date: 03/12/2024
Company: Endo International, Par Pharmaceutical
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Potential Presence of Silicone Particulate Matter

Multiple brands – Eye ointment products

Date: 02/26/2024
Company: Brassica Pharma Pvt. Ltd.
Dosage Form: Topical
Recall Issue Type: Contamination / Sterility
Recall Reason: Due to Potential Lack of Sterility Assurance.

Sustain, Schwinnng – Sustain and Schwinnng brand male enhancement capsules

Date: 02/05/2024
Company: Today the World
Dosage Form: Capsule
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Products contain undeclared Tadalafil and Nortadalafil

Arize – Arize brand male enhancement capsules

Date: 02/05/2024
Company: Today the World
Dosage Form: Capsule
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Products contain undeclared Nortadalafil

Neptune’s Fix – Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets

Date: 01/29/2024
Company: Neptune Resources, LLC
Dosage Form: Tablet
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Tianeptine

Zendedi – dextroamphetamine sulfate tablets, 30 mg

Date: 01/25/2024
Company: Azurity Pharmaceuticals, Inc.
Dosage Form: Tablet
Recall Issue Type: Labeling / Packaging
Recall Reason: Mislabeled package

Robitussin – Cough syrups

Date: 01/24/2024
Company: Haleon
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Microbial Contamination

Multiple brands – Lubricant Eye Drops & Multi-Symptom Eye Drops

Date: 01/22/2024
Company: Kilitch Healthcare India Limited
Dosage Form: Other / Unspecified
Recall Issue Type: Other Recall Issue
Recall Reason: Device & Drug Safety Potential Safety Concerns

Leiters, Compounding Health – Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags

Date: 01/08/2024
Company: Leiters Health
Dosage Form: Other / Unspecified
Recall Issue Type: Quality / Potency
Recall Reason: Potential for superpotent drug

Multiple brands – Lubricant Eye Drops & Multi-Symptom Eye Drops

Date: 11/15/2023
Company: Kilitch Healthcare India Limited
Dosage Form: Other / Unspecified
Recall Issue Type: Other Recall Issue
Recall Reason: Device & Drug Safety Potential Safety Concerns

Rugby – OTC Ophthalmic Sterile Drops

Date: 11/01/2023
Company: The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories
Dosage Form: Other / Unspecified
Recall Issue Type: Other Recall Issue
Recall Reason: Insanitary manufacturing conditions

KVK Tech – Betaxolol Tablets, USP

Date: 10/03/2023
Company: KVK-Tech, Inc.
Dosage Form: Tablet
Recall Issue Type: Other Recall Issue
Recall Reason: Potential Presence of Oxycodone HCl tablet