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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AllContamination / SterilityLabeling / PackagingUndeclared Ingredient
Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only,
Date: 09/03/2015
Product: Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Company: Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Recall Reason: Lack of Assurance of Sterility:  A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Category: Class II
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Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC
Date: 07/14/2015
Product: Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
Company: KVK-Tech, Inc.
Recall Reason: Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Category: Class III
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Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet
Date: 06/26/2015
Product: Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons.  Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21.
Company: American Health Packaging
Recall Reason: Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Category: Class III
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Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Date: 06/02/2015
Product: Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Company: The Compounding Pharmacy of America
Recall Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Category: Class II
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HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of
Date: 06/02/2015
Product: HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
Company: The Compounding Pharmacy of America
Recall Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Category: Class II
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BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG
Date: 03/10/2015
Product: BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized)  : TESTO (Testosterone USP) : DHEA  (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Company: the Compounder
Recall Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Category: Class II
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Methyl Folate Calcium active pharmaceutical ingredient packaged in varying grams or kg
Date: 11/14/2014
Product: Methyl Folate Calcium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Company: Attix Pharmaceuticals
Recall Reason: Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Category: Class II
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Homatropine Methylbromide active pharmaceutical ingredient packaged in varying grams or kg in
Date: 11/14/2014
Product: Homatropine Methylbromide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Company: Attix Pharmaceuticals
Recall Reason: Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Category: Class II
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HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative
Date: 10/06/2014
Product: HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Company: Oregon Compounding Centers, Inc. dba Creative Compounds
Recall Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Category: Class II
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VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured
Date: 07/08/2014
Product: VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company,  Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709  NDC 63010-027-70
Company: Pfizer Inc.
Recall Reason: Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016.  The correct expiry date is 09/2016.
Category: Class III
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Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP,
Date: 04/11/2014
Product: Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg  (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) Our Family 4 fl oz bottle, Distributed by Nash Finch Company, NFC Brands, MPLS, MN 55435, UPC 070253579523, C) Premier Value 4, 8 fl oz bottle, Distributed by Chain Drug Consortium, LLC., Boca Raton, FL 33431, 4 fl oz UPC 840986024719;  8 fl oz UPC 840986024726, NDC 68016-177-XX,  D) Rexall  4 fl oz bottle, Packaged for Dolencorp, LLC, Goodlettsville, TN 37072, UPC 715256714044, E) Safeway  4 fl oz, Distributed by Safeway INC, Pleasanton, CA 94566-0009, UPC 321130763581; F) Select Brand 4, 8 fl oz, Distributed by Select Brand Distributers, Pine Bluff, AR 71603, 4 fl oz UPC 015127024303; 8 fl oz UPC 015127024310.
Company: Aaron Industries Inc
Recall Reason: Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Category: Class III
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Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward
Date: 11/07/2013
Product: Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets.  Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.
Company: West-Ward Pharmaceutical Corp.
Recall Reason: Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Category: Class II
View Details View FDA Recall Listings
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