FDA Recall
Terminated
Historical recordClass II
Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
- Published
- November 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
by Precision Dose Inc.
- Reason
- cGMP Deviations: Product manufactured with contaminated raw ingredient.
- Published
- November 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
by Precision Dose Inc.
- Reason
- cGMP Deviations: Product manufactured with contaminated raw ingredient.
- Published
- November 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50
by Ascend Laboratories LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- November 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Simply Delicious, Inc.
- Product
- Bobo's Almond Butter Protein Bar, 2.2 oz., 4-pack Multipack,…
- Reason
- Almond Butter Bars contain undeclared peanuts.
- Published
- November 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
NOW Health Group Inc.
- Product
- NOW Bee Pollen 500mg 100 VCAPS UPC 733739025203
- Reason
- Product may contain Metronidazole
- Published
- November 17, 2021
- Distribution
- Total number of domestic consignees = 15…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
NOW Health Group Inc.
- Product
- NOW Ginseng & Royal Jelly 90 VCAPS UPC 733739040077 MMA Nutr…
- Reason
- Product may contain Metronidazole
- Published
- November 17, 2021
- Distribution
- Total number of domestic consignees = 15…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
NOW Health Group Inc.
- Product
- NOW Royal Jelly 1500mg 60 VCAPS UPC 733739025654 NOW Royal…
- Reason
- Product may contain Metronidazole
- Published
- November 17, 2021
- Distribution
- Total number of domestic consignees = 15…
View recall →
FDA Recall
Terminated
Historical recordClass I
Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01
by MERCK SHARP & DOHME CORP
- Reason
- Presence of Particulate Matter: Identified as Glass Particles
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass I
Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504
by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Reason
- Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA, , packaged in bottles.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- Published
- November 10, 2021
- Distribution
- Nationwide
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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