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 →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ProSource Produce LLC
- Product
- Whole raw WHITE onions are imported from Chihuahua of MEXICO…
- Reason
- Salmonella Oranienburg.
- Published
- November 10, 2021
- Distribution
- Distributed in AL, AR, AZ, CA, CO, CT, F…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ProSource Produce LLC
- Product
- Whole raw YELLOW onions are imported from Chihuahua of MEXIC…
- Reason
- Salmonella Oranienburg.
- Published
- November 10, 2021
- Distribution
- Distributed in AL, AR, AZ, CA, CO, CT, F…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ProSource Produce LLC
- Product
- Whole raw RED onions are imported from Chihuahua of MEXICO.…
- Reason
- Salmonella Oranienburg.
- Published
- November 10, 2021
- Distribution
- Distributed in AL, AR, AZ, CA, CO, CT, F…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
NSE Products, Inc.
- Product
- Pharmanex Kids Jungamals, Dietary Supplement 90 Chewable Tab…
- Reason
- Pharmanex Jungamals was found to have a missing fish allergen statement on the label due to fish gelatin as a sub-component of the Vitamin E ingredient.
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pepsico Inc
- Product
- Starbucks Doubleshot Espresso, Espresso & Salted Caramel Cre…
- Reason
- An issue with adequate sealing of canned coffee products potentially lead to premature spoilage.
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pepsico Inc
- Product
- Starbucks Doubleshot Espresso, Espresso & Light Cream, 6.5 F…
- Reason
- An issue with adequate sealing of canned coffee products potentially lead to premature spoilage.
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pepsico Inc
- Product
- Starbucks Doubleshot Espresso, Espresso & Cream, 6.5 FL OZ U…
- Reason
- An issue with adequate sealing of canned coffee products potentially lead to premature spoilage.
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41
by MACLEODS PHARMA USA, INC
- Reason
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41
by MACLEODS PHARMA USA, INC
- Reason
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
by MACLEODS PHARMA USA, INC
- Reason
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 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.
Read the full medical disclaimer.