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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M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In
Date: 05/13/2016
Product: M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%)  METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Company: Medaus, Inc.
Recall Reason: Lack of Assurance of Sterility
Category: Class II
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M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1
Date: 05/13/2016
Product: M.I.C B-COMPLEX PREMIX W/HYDROXY B12  W/PRES. (BENZALKONIUM 0.01%)  HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG,  B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG,  METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY
Company: Medaus, Inc.
Recall Reason: Lack of Assurance of Sterility
Category: Class II
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2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9%
Date: 05/05/2016
Product: 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48
Company: Pharmedium Services, LLC
Recall Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Category: Class II
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All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY,
Date: 03/25/2016
Product: All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
Company: Reliable Rexall-A Compounding Pharmacy
Recall Reason: Lack of Processing Controls
Category: Class II
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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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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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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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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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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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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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