FDA Recall
🇺🇸 United States
TerminatedTerminated: September 29, 2020Historical recordClass II
CHICAGO BAR COMPANY LLC RXBAR
- Product
- Coconut Chocolate RXBARs , 1.83 oz., single bar, , 12-count…
- Reason
- Chicago Bar Company LLC d/b/a RXBAR is voluntary recalling certain varieties of bars due to undeclared allergen peanut.
- Published
- February 20, 2019
- Distribution
- Domestic:AL, AR, AZ,CA, CO, CT, DC, DE,…
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FDA Recall
TerminatedTerminated: June 22, 2020Historical recordClass III
Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
- Published
- February 13, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 6, 2023Historical recordClass II
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
by US Pharmaceuticals Inc.
- Reason
- GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
- Published
- February 13, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 6, 2023Historical recordClass II
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03
by US Pharmaceuticals Inc.
- Reason
- GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
- Published
- February 13, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 6, 2023Historical recordClass II
Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22
by US Pharmaceuticals Inc.
- Reason
- GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
- Published
- February 13, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 9, 2019Historical recordClass II
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.
by Mylan Pharmaceuticals Inc.
- Reason
- Defective Container: Potential for broken glass in the neck area of the glass bottles.
- Published
- February 13, 2019
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 3, 2021Historical recordClass I
Barcelona Nut Company
- Product
- Barcelona Nut Company, Roasted and Salted Select Inshell Pis…
- Reason
- Barcelona Nut Company has initiated a recall of Roasted and Salted Select In shell Pistachios 21/25, flexible package, shelf life of one year because of salmonella contamination.
- Published
- February 13, 2019
- Distribution
- There are no Government accounts. States…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 26, 2019Historical recordClass I
Funky Chunky LLC
- Product
- Nutty Choco Pop, 10 oz. bag. Sold in the following configur…
- Reason
- Nutty Choco Pop has in incorrect label and does not declare that it contains cashews and almonds.
- Published
- February 13, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 9, 2019Historical recordClass II
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
- Published
- February 6, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 22, 2021Historical recordClass II
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41
by Sun Pharmaceutical Industries, Inc.
- Reason
- Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
- Published
- February 6, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 6, 2021Historical recordClass II
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
by H J Harkins Company Inc dba Pharma Pac
- Reason
- Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
- Published
- February 6, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 15, 2022Historical recordClass II
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
by Akorn, Inc.
- Reason
- Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
- Published
- February 6, 2019
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-03
by Prinston Pharmaceutical Inc
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Published
- February 6, 2019
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 90 count NDC 43547-331-09
by Prinston Pharmaceutical Inc
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Published
- February 6, 2019
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 30 count - NDC 43547-331-03
by Prinston Pharmaceutical Inc
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Published
- February 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-09
by Prinston Pharmaceutical Inc
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Published
- February 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09
by Prinston Pharmaceutical Inc
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Published
- February 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 5, 2019Historical recordClass I
Fine Land Corp
- Product
- Meiqili Durian Candy in plastic bag with clear window, Net W…
- Reason
- Product contains undeclared milk.
- Published
- February 6, 2019
- Distribution
- Connecticut, New York, Philadelphia, Vir…
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FDA Recall
TerminatedTerminated: February 17, 2023Historical recordClass II
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
by LUPIN SOMERSET
- Reason
- Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
- Published
- January 30, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 3, 2020Historical recordClass II
Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10
by Dr. Reddy's Laboratories, Inc.
- Reason
- Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
- Published
- January 30, 2019
- Distribution
- Nationwide
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Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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