FDA Recall
Completed
Historical recordClass II
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905
by Hetero Labs Limited Unit V
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass II
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908
by Hetero Labs Limited Unit V
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307
by Hetero Labs Limited Unit V
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
- Published
- August 29, 2018
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0
by A-S Medication Solutions LLC.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0
by A-S Medication Solutions LLC.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by A-S Medication Solutions LLC.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by A-S Medication Solutions LLC.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gourmet International Inc.
- Product
- SPARKLING SOUR CHERRY JUICE DRINK, 6/34 oz., glass bottles
- Reason
- Gourmet International Inc. is voluntarily recalling LItaly Sparkling Juice Beverages due to packaging concerns following multiple reports of leaking caps.
- Published
- August 29, 2018
- Distribution
- Domestic: IL MI WI CA…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gourmet International Inc.
- Product
- SPARKLING POMEGRANETE JUICE DRNK, 6/34 oz., glass bottles
- Reason
- Gourmet International Inc. is voluntarily recalling LItaly Sparkling Juice Beverages due to packaging concerns following multiple reports of leaking caps.
- Published
- August 29, 2018
- Distribution
- Domestic: IL MI WI CA…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gourmet International Inc.
- Product
- SPARKLING MANDARIN JUICE DRINK, 6/34 oz., glass bottles
- Reason
- Gourmet International Inc. is voluntarily recalling LItaly Sparkling Juice Beverages due to packaging concerns following multiple reports of leaking caps.
- Published
- August 29, 2018
- Distribution
- Domestic: IL MI WI CA…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gourmet International Inc.
- Product
- SPARKLING LIME JUICE DRINK, 6/34 oz, glass bottles
- Reason
- Gourmet International Inc. is voluntarily recalling LItaly Sparkling Juice Beverages due to packaging concerns following multiple reports of leaking caps.
- Published
- August 29, 2018
- Distribution
- Domestic: IL MI WI CA…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gourmet International Inc.
- Product
- SPARKLING LEMON JUICE DRINK , 6 /34 oz., glass bottles
- Reason
- Gourmet International Inc. is voluntarily recalling LItaly Sparkling Juice Beverages due to packaging concerns following multiple reports of leaking caps.
- Published
- August 29, 2018
- Distribution
- Domestic: IL MI WI CA…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gourmet International Inc.
- Product
- SPARKLING GRAPEFRUIT JUICE DRINK, 6/34 oz., glass bottles
- Reason
- Gourmet International Inc. is voluntarily recalling LItaly Sparkling Juice Beverages due to packaging concerns following multiple reports of leaking caps.
- Published
- August 29, 2018
- Distribution
- Domestic: IL MI WI CA…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Country Favor Inc.
- Product
- BEST TASTE BRAND SNACK GINGER SLICED, Net Weight 200g, 7 OZ,…
- Reason
- Product contains high levels of undeclared sulfites.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Bow Tie Pasta Caesar Molly's Kitchen, item # 58108.76434, In…
- Reason
- Bow Tie Pasta Caesar Molly's Kitchen is recalled due to a potential contamination with Cyclospora. The pasta salad contains spinach that was recalled due to a potential contamination with Cyclospora.
- Published
- August 29, 2018
- Distribution
- Distributed in AZ, CA, GA, ID, KS, MI, M…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Bow Tie Florentine Reser's Fine Foods, item # 71117.15314,…
- Reason
- Bow Tie Florentine Reser's Fine Food is recalled due to a potential contamination with Cyclospora. The pasta salad contains spinach that was recalled due to a potential contamination with Cyclospora.
- Published
- August 29, 2018
- Distribution
- Distributed in AZ, CA, GA, ID, KS, MI, M…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Three Cheese Pasta Spinache Stonemill Kitchens, item # 71117…
- Reason
- Three Cheese Pasta Spinache Stonemill Kitchens is recalled due to a potential contamination with Cyclospora. The pasta salad contains spinach that was recalled due to a potential contamination with Cyclospora.
- Published
- August 29, 2018
- Distribution
- Distributed in AZ, CA, GA, ID, KS, MI, M…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Pasta Spinach with Cavatappi, Reser's Fine Food, item # 7111…
- Reason
- Pasta Spinach with Cavatappi Reser's Fine Food is recalled due to a potential contamination with Cyclospora. The pasta salad contains spinach that was recalled due to a potential contamination with Cyclospora.
- Published
- August 29, 2018
- Distribution
- Distributed in AZ, CA, GA, ID, KS, MI, M…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
SALT & STRAW LLC
- Product
- Chocolate Gooey Brownie Ice Cream, packaged in pint-sized co…
- Reason
- Chocolate Gooey Brownie Ice Cream is recalled due to possible undeclared peanuts.
- Published
- August 29, 2018
- Distribution
- Distributed in CA, OR, and WA. Firm a…
View recall →
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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