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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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
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Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa
Date: 03/25/2019
Product: Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01
Company: Lohxa LLC
Recall Reason: Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Category: Class II
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Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals
Date: 03/13/2019
Product: Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11
Company: Lupin Pharmaceuticals Inc.
Recall Reason: Defective Container: Repetitive complaints received indicating pump not working.
Category: Class III
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PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd.
Date: 02/21/2019
Product: PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
Company: Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
Recall Reason: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Category: Class II
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Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20),
Date: 01/02/2019
Product: 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 Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Company: Lupin Pharmaceuticals Inc.
Recall Reason: CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Category: Class II
View Details View FDA Recall Listings
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