FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.
by Ascent Pharmaceuticals, Inc.
- Reason
- Product Mix-up
- Published
- December 15, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2023Historical recordClass III
Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed dissolution specifications
- Published
- December 15, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2023Historical recordClass III
Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed dissolution specifications
- Published
- December 15, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2023Historical recordClass III
Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed dissolution specifications
- Published
- December 15, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2023Historical recordClass III
12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed dissolution specifications
- Published
- December 15, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2023Historical recordClass III
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed dissolution specifications
- Published
- December 15, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2023Historical recordClass III
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed dissolution specifications
- Published
- December 15, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2023Historical recordClass III
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed dissolution specifications
- Published
- December 15, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2023Historical recordClass III
Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed dissolution specifications
- Published
- December 15, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2023Historical recordClass III
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-7388-5.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed dissolution specifications
- Published
- December 15, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass I
AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2
by American Screening LLC
- Reason
- Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
- Published
- December 15, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 12, 2022Historical recordClass II
Trader Joes Company
- Product
- Trader Joe's Organic Blue Corn Tortilla Chips: 16 oz. bag, 1…
- Reason
- Popcorn containing butter (milk) was found co-mingled with Trader Joe's Organic Blue Corn Tortilla Chips - undeclared milk allergen.
- Published
- December 15, 2021
- Distribution
- DC's in IL, PA and then to retail locati…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 31, 2023Historical recordClass II
CONAGRA BRANDS
- Product
- Birds Eye Broccoli Tots, frozen, 12OZ bag UPC 00-0-14500-001…
- Reason
- Small rocks and metal fragments in the product
- Published
- December 15, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical 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
TerminatedTerminated: July 12, 2023Historical 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
TerminatedTerminated: November 15, 2022Historical 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
TerminatedTerminated: April 30, 2024Historical recordClass II
Murray International Trading Co., Inc.
- Product
- "Herbal Doctor" brand Angelicae Sinensis, Natural Herb, Net…
- Reason
- Product contains elevated levels of lead and cadmium
- Published
- December 8, 2021
- Distribution
- NY, NJ, PA, MA, CT, Washington DC, VA, D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 23, 2022Historical 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
TerminatedTerminated: June 23, 2022Historical 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
TerminatedTerminated: June 23, 2022Historical 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 →
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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