FDA Recall
Completed
Historical recordClass I
Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64
by Sandoz Inc
- Reason
- Temperature Abuse; temperature excursion during shipping
- Published
- December 8, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66
by Pfizer Inc.
- Reason
- Lack of sterility assurance: bag has the potential to leak.
- Published
- December 8, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated, Manufactured by: Lupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13.
by Lupin Pharmaceuticals Inc.
- Reason
- Subpotent Drug
- Published
- December 8, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
KEURIG DR PEPPER
- Product
- Target Good & Gather Mixed Berry Sparkling Water 8 pack of 1…
- Reason
- The company has received off flavor and off aroma complaints identified with the recalled lot. After analysis it was found that the products contained unlabeled sulfites.
- Published
- December 8, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
KEURIG DR PEPPER
- Product
- Target Good & Gather Coconut Pineapple Sparkling Water 8 pac…
- Reason
- The company has received off flavor and off aroma complaints identified with the recalled lot. After analysis it was found that the products contained unlabeled sulfites.
- Published
- December 8, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
KEURIG DR PEPPER
- Product
- Polar Black Cherry Premium Seltzer 12 pack of 12oz cans UPC…
- Reason
- The company has received off flavor and off aroma complaints identified with the recalled lot. After analysis it was found that the products contained unlabeled sulfites.
- Published
- December 8, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
KEURIG DR PEPPER
- Product
- 7UP Zero Sugar Lemon Lime Soda 12 pack of 12 oz. can UPC Car…
- Reason
- The company has received off flavor and off aroma complaints identified with the recalled lot. After analysis it was found that the products contained unlabeled sulfites.
- Published
- December 8, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Onions 52
- Product
- 40# (LB) Ctn (box) Jumbo Yellow Onions, Product of Mexico -…
- Reason
- Voluntary recall due to possible contamination with Salmonella Oranienburg in onions from Chihuahua Mexico.
- Published
- December 8, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Onions 52
- Product
- 12 count per 2 lb. mesh sacks with UPC 033383 601014 Medium…
- Reason
- Voluntary recall due to possible contamination with Salmonella Oranienburg in onions from Chihuahua Mexico.
- Published
- December 8, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Onions 52
- Product
- 5# (LB) Ctn (box) Jumbo Red Onions, Product of Mexico - Labe…
- Reason
- Voluntary recall due to possible contamination with Salmonella Oranienburg in onions from Chihuahua Mexico.
- Published
- December 8, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05
by Aurobindo Pharma USA Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- December 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.
by Teligent Pharma, Inc.
- Reason
- Defective Container
- Published
- December 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05
by Teligent Pharma, Inc.
- Reason
- Defective Container
- Published
- December 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03, barcode 083923153776, e) 90-count bottles, NDC: 71335-1767-04, barcode 083924152889, f) 120-count bottles, NDC: 71335-1767-07, barcode 083927153735. Westminster Pharmaceuticals LLC, Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504 USA
by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Reason
- Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
- Published
- December 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504.
by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Reason
- Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
- Published
- December 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.
by UNICHEM PHARMACEUTICALS USA INC
- Reason
- Discoloration
- Published
- December 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
MARY RUTH ORGANICS
- Product
- MaryRuth's Organic Infants Liquid Probiotic; Unflavored, a…
- Reason
- Internal testing found the presence of Pseudomonas aeruginosa in the product.
- Published
- December 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2
by Bayer Healthcare Pharmaceuticals Inc.
- Reason
- cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
- Published
- November 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
by Bayer Healthcare Pharmaceuticals Inc.
- Reason
- Chemical Contamination: presence of benzene
- Published
- November 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5
by Bayer Healthcare Pharmaceuticals Inc.
- Reason
- Chemical Contamination: presence of benzene
- Published
- November 24, 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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