Drug Recall Records

This page shows recent human drug recall alerts sourced from the FDA. It includes current and some previously imported records, but is not a complete historical archive of all past recalls. For full historical data, visit the official FDA Drug Recalls page. Always consult a healthcare professional for medical advice.

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Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx
Date: 04/15/2020
Product: Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
Company: Amneal Pharmaceuticals of New York, LLC
Recall Reason: CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Category: Class II
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Edema Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)
Date: 03/24/2020
Product: Edema Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Company: Herbal Doctor Remedies
Recall Reason: CGMP Deviations: These products have been found to be misbranded as  unapproved new drugs
Category: Class II
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Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use,
Date: 01/15/2020
Product: Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-060-3
Company: Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Recall Reason: Lack of Assurance of Sterility
Category: Class II
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Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx
Date: 08/30/2019
Product: Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
Company: Pacifico National, Inc. dba AmEx Pharmacy
Recall Reason: Lack of assurance of sterility.
Category: Class II
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Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by:
Date: 07/29/2019
Product: Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810  Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810  NDC 65862-053-99
Company: Aurobindo Pharma USA Inc.
Recall Reason: Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Category: Class III
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Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)
Date: 07/12/2019
Product: Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Company: Herbal Doctor Remedies
Recall Reason: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Category: Class II
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CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl.
Date: 07/02/2019
Product: CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Company: Altaire Pharmaceuticals, Inc.
Recall Reason: Lack of Assurance of Sterility
Category: Class II
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INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in
Date: 06/12/2019
Product: INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Company: Infusion Options, Inc.
Recall Reason: Lack of Assurance of Sterility
Category: Class II
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Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924
Date: 06/12/2019
Product: Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Company: Infusion Options, Inc.
Recall Reason: Lack of Assurance of Sterility
Category: Class II
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LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count
Date: 06/06/2019
Product: LOSARTAN POTASSIUM 50 mg TABLET BULK  90 count bottles and 1000 count bottles, NDC 00591-3746-00
Company: Teva Pharmaceuticals USA
Recall Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Category: Class II
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Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304
Date: 05/23/2019
Product: Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Company: Pharm D Solutions, LLC
Recall Reason: Lack of Sterility Assurance.
Category: Class II
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Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by:
Date: 04/10/2019
Product: Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202  NDC 43386-542-01
Company: LUPIN SOMERSET
Recall Reason: Failed Impurities/Degradation Specifications
Category: Class III
View Details View FDA Recall Listings
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