Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
3 Class I (most serious) drug recalls reported in the last 30 days.
3,250 recalls
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Class II Ongoing
Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Lots / codes
- Expiry, lot: [30-count] 11/30/2018: 7258177, 7276228; 2/28/2019: 7212260; [90-count] 11/30/2018: 7208140; 2/28/2019: 7212261, 7221155, 7222161; 8/31/2019: 8109171; 9/30/2019: 8109170
- Distribution
- Nationwide USA
- Quantity
- 178 bottles
- Recall started
- July 17, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1109-2018
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Class II Ongoing
Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Lots / codes
- Expiry, lot: [30-count] 2/28/2019: 7285177; 3/31/2019: 7222163, 7227175; 8/31/2019: 8162190, 8183227. [90-count] 2/28/2019: 7207135, 7212280, 7215073; 3/31/2019: 7222162; 8/31/2019: 8095248, 8095249
- Distribution
- Nationwide USA
- Quantity
- 666 bottles
- Recall started
- July 17, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1108-2018
-
Class II Ongoing
Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany,…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.
- Lots / codes
- NDC 0591-2170-19 Lot Numbers: 1208002A, 1247282M, 1263944M NDC 0591-2170-05 Lot Numbers: 1208000M, 1208001M, 1240425A
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Quantity
- 13,555 90-count bottles; 2,892 500-count bottles
- Recall started
- July 16, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0989-2018
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Class II Ongoing
Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
- Lots / codes
- NDC 0591-2169-19 Lot Numbers: 1177880A, 1220831A, 1263941A NDC 0591-2169-10 1175922M, 1220826M, 1236294M, 1240427M, 1270616A
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Quantity
- 15,347 90-count bottles, 8,378 1000-count bottles
- Recall started
- July 16, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0988-2018
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Class II Ongoing
Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany,…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
- Lots / codes
- Lot Numbers: NDC 0591-2168-19 1175947M, 1175948M, 1177115A, 1219361A, 1240434M, 1250704M NDC 0591-2168-10 1177114A, 1219360M, 1250706A
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Quantity
- 30,793 90-count bottles, 1,158 1000-count bottles
- Recall started
- July 16, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0987-2018
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Class II Ongoing
Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, N…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
- Lots / codes
- Lot Numbers: NDC 0591-2167-30 1196936A, 1238463A, 1270617A NDC 0591-2167-19 1196934M, 1238462M, 1268429A
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Quantity
- 8,046 30-count bottles, 20,841 90-count bottles
- Recall started
- July 16, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0986-2018
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Class II Ongoing
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19.
- Lots / codes
- Lot Numbers: 1191188M, 1191189M, 1191190M, 1199220M, 1217576M, 1217577M, 1217578M, 1220832M, 1220833M, 1247283M, 1247284M, 1247285M, 1247286M, 1247287A, 1280632M, 1280633M
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Quantity
- 164,922 bottles
- Recall started
- July 16, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0985-2018
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Class II Ongoing
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19
- Lots / codes
- Lot Numbers: 1191185M, 1191186M, 1225615M, 1233948M, 1250718M, 1253257M
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Quantity
- 64,168 bottles
- Recall started
- July 16, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0984-2018
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Class II Ongoing
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 070…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2317-19.
- Lots / codes
- Lot Numbers: 1191164M, 1191165M, 1191166M, 1191167A, 1225612M, 1250717M, 1256111M, 1288798M
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Quantity
- 99,554 bottles
- Recall started
- July 16, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0983-2018
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Class II Ongoing
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 0…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2316-19.
- Lots / codes
- Lot Numbers: 1191160M, 1191161M, 1191162A, 1219363M, 1219364M, 1219365A, 1225613A, 1233944M, 1233945M, 1253253M, 1253254M
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Quantity
- 195,234 bottles
- Recall started
- July 16, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0982-2018
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Class II Ongoing
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, ND…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19.
- Lots / codes
- Lot # 1191191M, 1191192M, 1191193M, 1191194M, 1191195M, 1238466M, 1238467M, 1253261M 1256125M, 1277709M
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Quantity
- 56,603 bottles
- Recall started
- July 16, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0981-2018
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Class II Ongoing
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed b…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-315-09
- Lots / codes
- All lots within expiry.
- Distribution
- United States
- Quantity
- N/A
- Recall started
- July 13, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0976-2018
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Class II Ongoing
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-314-09
- Lots / codes
- All lots within expiry.
- Distribution
- United States
- Quantity
- N/A
- Recall started
- July 13, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0975-2018
-
Class II Ongoing
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-313-09
- Lots / codes
- All lots within expiry
- Distribution
- United States
- Quantity
- N/A
- Recall started
- July 13, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0974-2018
-
Class II Ongoing
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-312-09
- Lots / codes
- All lots within expiry.
- Distribution
- United States
- Quantity
- N/A
- Recall started
- July 13, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0973-2018
-
Class II Ongoing
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-311-09
- Lots / codes
- All lots within expiry.
- Distribution
- United States
- Quantity
- N/A
- Recall started
- July 13, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0972-2018
-
Class II Ongoing
Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranb…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-370-09
- Lots / codes
- All lots within expiry.
- Distribution
- United States
- Quantity
- N/A
- Recall started
- July 13, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0971-2018
-
Class II Ongoing
Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cra…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-369-09
- Lots / codes
- All lots within expiry.
- Distribution
- United States
- Quantity
- N/A
- Recall started
- July 13, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0970-2018
-
Class II Ongoing
Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranb…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-368-09
- Lots / codes
- All lots within expiry.
- Distribution
- United States
- Quantity
- N/A
- Recall started
- July 13, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0969-2018
-
Class II Ongoing
Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cra…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-367-03
- Lots / codes
- All lots within expiry.
- Distribution
- United States
- Quantity
- N/A
- Recall started
- July 13, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0968-2018
-
Class II Ongoing
Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample – Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0…
Reason: Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Lots, distribution and details
- Product
- Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample – Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00
- Lots / codes
- Lot #: 7F021B, Exp 6/30/20
- Distribution
- Nationwide
- Quantity
- 3214 prefilled pens
- Recall started
- July 5, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0925-2018
-
Class I Ongoing
Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
Reason: Non-sterility – presence of bacteria confirmed by outside laboratory after day 14.
Lots, distribution and details
- Product
- Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
- Lots / codes
- Lot # 22016, Exp 1/30/2017
- Distribution
- Nationwide and Puerto Rico
- Quantity
- 49 vials
- Recall started
- April 2, 2016 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0918-2017
-
Class I Ongoing
Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
Reason: Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Lots, distribution and details
- Product
- Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
- Lots / codes
- Lot # 2079ps5, Exp 02/01/2016
- Distribution
- Distributed throughout Florida
- Quantity
- 1890 syringes
- Recall started
- December 29, 2015 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0917-2017
-
Class I Ongoing
Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10
Reason: Presence of Particulate Matter: human hair found within an internal sample syringe.
Lots, distribution and details
- Lots / codes
- Lot 58382EV*, Exp 1OCT 2017, *lot may be followed by 01 or 02
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 71,550 syringes
- Recall started
- April 21, 2017 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0862-2017
-
Class II Ongoing
Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.
Reason: Defective Delivery System: Elevated number of units with out of specification results for leak rate
Lots, distribution and details
- Lots / codes
- Lot#: 7ZP0634, 7ZP0810, 7ZP0990, Exp. 5/18
- Distribution
- Nationwide in the US and Puerto Rico
- Quantity
- 562,883
- Recall started
- May 16, 2017 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0793-2017
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 5, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.