The Drug Recall Report is for prescription drugs that are have recently been issued recalls by the U.S. Food and Drug Administration (FDA). Here’s what you should do if your prescription medications are recalled:  

  • Do not continue to use any recalled prescription medicine
  • Contact your provider or pharmacist if you have experienced any reactions.
  • Check your prescription label for the drug lot number and the expiration date to see if any of your medication is affected by the recall.
  • If you have the medication, contact the pharmacy that you received it from. Any adverse actions or events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

More information about these recalls is available at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

Losartan 

On 5/3/2019, Heritage Pharmaceuticals Inc. recalled Losartan 25mg, 50mg, 100mg tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

On 2/28/2019, Camber Pharmaceuticals Inc. recalled Losartan 25mg, 50mg, 100mg tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

On 4/10/2019, Torrent Pharma, Inc. recalled losartan potassium tablets due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=171978

The detailed information of the recalled product is listed below:

Recalled drug: Losartan 25mg, 50mg, 100 mg tablets | Losartan Potassium Tablets (all strengths) 

NDC numbers: 31722070010, 31722070130, 31722070290
Lot numbers:
Due to the high volume of lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number related to your medication. 

Acyclovir 400mg tablets

On 4/25/2019, Zydus Pharmaceuticals recalled Acyclovir 400mg tablets due to a tablet mix-up. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=172494

The detailed information of the recalled product is listed below:

Recalled drug:  Acyclovir 400mg tablets, 100 count bottles
NDC number: 
68382079101
Lot numbers:
Z804517
Expiration date:
11/30/2020

Fentanyl Transdermal Patch, 12mcg/hr

On 4/19/2019, Alvogen, Inc recalled Fentanyl 12mcg/hr transdermal patches due to a packaging mix-up leading to the incorrect strength in respective boxes. The U.S. Food and Drug Administration (FDA) has issued a Recall Class I of the affected medications.

More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=172322

The detailed information of the recalled product is listed below:

Recalled drug: Fentanyl 12mcg/hr transdermal patch
NDC number:
47781042347
Lot numbers and expiration date:
Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.

View past recalls still in effect:

Irbesartan 300 mg Tablets

On 1/18/2019, Prinston Pharmaceutical Inc. recalled Irbesartan 300mg Tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=170280

The detailed information of the recalled product is listed below:

Recalled Drug: Irbesartan 300mg Tablets
NDC Number:
43547-376-09
Lot Numbers:
331B18009

Valsartan, Valsartan-Hydroclorothiazide & Amlodipine-Valsartan

On 1/18/2019, Aurobindo Pharma USA Inc. recalled Valsartan 160mg, 320mg, 40mg, 80mg tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

Recalled Drug: Valsartan 160mg, 320mg, 40mg, 80mg tablets

NDC number: 65862057290, 65862057390, 65862057030, 65862057190

Lot numbers: Due to the high volume of Lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number related to your medication. More information about the recall is available at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=171206 

Quetiapine Fumarate 400mg

On November 14, 2018, ASCEND LABORATORIES recalled QUETIAPINE FUMARATE 400 MG due to the presence of a foreign substance. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. This is an ongoing FDA drug recall.

Recalled Drug: Quetiapine Fumarate 400mg

NDC Number: 67877024801

Lot Number: 7143908

Expiration Date: November 2020

Valsartan, Valsartan-Hydroclorothiazide & Amlodipine-Valsartan

On November 20, 2018 Mylan recalled Amlodipine-Valsartan &  Valsartan due to the detection of trace amounts of the impurity NDEA (N-Nitrosodiethylamine) found in the active pharmaceutical ingredient of Valsartan. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

Recalled Drug: 

  • Valsartan 40 mg, 60 mg, 80 mg, 160 mg, and 320 mg
  • Amlodipine-Valsartan 5/160 mg, 10/160 mg and 10/320 mg
  • Valsartan-Hydrochlorathiazide 320/25 MG 

NDC Number: 00378-1721-93, 00378-1722-93, 00378-1724-93, 00378-5813-77, 00378-5814-77, 00378-5807-93, 0378-5815-77 and 0378-6325-05

Lot Number: 3079500, 3061986, 3079709, 3077618, 3079708, 3063782, 3071352, 3061169, 3081499, 3080009, 3080010, 3079205, 3084886, 3093804

Expiration Date:  November 2018, January 2019, March 2019, July 2019, November 2019, December 2019, January 2020, February 2020, March 2020

Tizanidine HCL 2 mg

On 09/04/2018, Dr. Reddy’s Lab recalled Tizanidine HCL 2 MG due to a tablet mix-up. Glimepiride tablets were found in bottles of Tizanidine.  The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medication.  

Recalled Drug: Tizanidine HCL 2 mg

NDC Number: 55111017915

Lot Numbers: T800304

Expiration Date: 03/2021

Diphenoxylate & Atropine 2.5 mg/0.025mg

On January 4, 2018, Pfizer Inc. recalled Diphenoxylate and Atropine 2.5 mg/0.025mg (NDC# 59762-1061-01 and 59762-1061-02) due to weight variations resulting in tablets that are the incorrect strength. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #1 of the affected medications.

Recalled Drug: Diphenoxylate and Atropine 2.5 mg/0.025mg

NDC Number: 59762-1061-01 and 59762-1061-02

Lot Number: R83962, R93347, R93348, R93349, R93350, R93351, R93352, R93356, R93357, R93358, R97310, S57831, S57832, S57834

Expiration Date: 2021 OCT 31, 2021 NOV 30

Fluticasone 50mcg

On 05/31/2018, Apotex Corp recalled Fluticasone 50mcg due to the potential presence of embedded and loose particles within the medication. The U.S. Food and Drug Administration (FDA) has issued a Class 2 recall of the affected medications.

Recalled Drug: Fluticasone 50mcg

NDC Number: 60505-0829-01

Lot Number: NJ4501

Expiration Date: 07/2020

Metoprolol Succinate 100 mg

On 05/09/2018 Dr. Reddy’s Laboratories recalled Metoprolol Succinate 100 MG due to due to tablet mix- up. Clopidogrel tablets were found in bottles of Metoprolol. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #2 of the affected medications.

Recalled Drug: Metoprolol Succinate 100 mg

NDC Number: 55111-0468-01

Lot Number:  C706254

Expiration Date: 08/2019

Fluoxetine HCL 10 mg Tablet

On 2/5/2018, Teva Pharmaceuticals IND recalled Lot # 732259, 732260, 732261, 732262, 732263, 732264, 732265, 732266, 732267, 732268, 732269, 732270, 732272, 732273, 732274, 732275, 732276, 732277, 732278, 732280, 732281, 732282, 732283, 732284, 732285, 732286, 732287, 732288, 732289, 732293, 732294, 732296, 732297, 732295, 732298, 732299, 732300, 732301 of Fluoxetine HCL 10 mg

NDC# 00093718856 due to errors in the manufacturing process. The U.S. Food and Drug Administration (FDA) has issued an unclassified recall of the affected medications.

Recalled Drug: Fluoxetine HCL 10 mg Tablet
NDC Number: 00093718856
Lot Numbers: 32259, 732260, 732261, 732262, 732263, 732264, 732265, 732266, 732267, 732268, 732269, 732270, 732272, 732273, 732274, 732275, 732276, 732277, 732278, 732280, 732281, 732282, 732283, 732284, 732285, 732286, 732287, 732288, 732289, 732293, 732294, 732296, 732297, 732295, 732298, 732299, 732300, 732301
Expiration Date: All lots within expiry

Clopidogrel 75 Mg

On 01/04/2018, International Laboratories LLC recalled Lot Number 117099A of Clopidogrel 75 Mg. (NDC# 54458-0888-16) due to a labeling mix-up. Simvastatin tablets found in bottles labeled as Clopidogrel tablets. The U.S. Food and Drug Administration (FDA) has issued a Recall Class 1 of the affected medications. 

Recalled Drug: Clopidogrel 75 Mg
NDC Number: 54458-0888-16
Lot Numbers: 117099A
Expiration Date: Exp. 08/19

Pravastatin Sodium 10 and 20mg

On 01/12/2018, International Laboratories LLC., recalled Lot Numbers 1117093A and 117103A of PRAVASTATIN SODIUM 10 & 20 MG tablets (NDC# 54458-0927-16 and 54458-0926-16) due to a tablet mix-up. Bottles of medication could contain Pravastatin 10 mg and 20 mg tablets in the same bottle. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #2 of the affected medications.

Recalled Drug: Pravastatin 10 and 20mg

NDC Number: 54458-0927-16 and 54458-0926-16

Lot Numbers: 1117093A and 117103A

Expiration Date: Exp. 06/19 and Exp. 03/19

Divalproex Sodium DR 500 MG

On 01/17/2018, Unichem Pharmaceuticals USA Inc. recalled Lot Number ZDPH17040 of Divalproex Sodium DR 500 MG (NDC# 29300-0140-01) due to presence of an anti-fungal agent (metronidazole powder) found in one bottle. The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications.

Recalled Drug: Divalproex Sodium DR 500 MG
NDC Number: 29300-0140-01
Lot Numbers: ZDPH17040
Expiration Date: N/A

Diphenoxylate and Atropine 2.5 mg/0.025mg

On January 4, 2018, Pfizer Inc. recalled Diphenoxylate and Atropine 2.5 mg/0.025mg (NDC# 59762-1061-01 and 59762-1061-02) due to weight variations resulting in tablets that are the incorrect strength. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #1 of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Diphenoxylate and Atropine 2.5 mg/0.025mg

NDC Number: 59762-1061-01 and 59762-1061-02

Lot Number: R83962, R93347, R93348, R93349, R93350, R93351, R93352, R93356, R93357, R93358, R97310, S57831, S57832, S57834

Expiration Date: Oct 31, 2021, Nov 30, 2021

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