FDA Recall
TerminatedTerminated: September 11, 2023Historical recordClass II
allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811.
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 11, 2023Historical recordClass II
Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010.
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 11, 2023Historical recordClass II
Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 11, 2023Historical recordClass II
allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 11, 2023Historical recordClass II
Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave., Allegan, MI 49010 USA. NDC 63981-847-48
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 11, 2023Historical recordClass II
aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Perrigo Company, Allegan, MI USA 49010. NDC 55301-847-39
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 11, 2023Historical recordClass II
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 11, 2023Historical recordClass II
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, Salisbury, NC 28147. NDC 72476-847-22
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 11, 2023Historical recordClass II
Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale Club, 25 Research Drive, Westborough, MA 01581. NDC 68391-847-47
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 11, 2023Historical recordClass II
Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count cartons (NDC 72288-847-47 and 72288-847-37), Distributed By: Amazon.com Services LLC., 410 Terry Avenue N., Seattle, WA 98109.
by L. Perrigo Company
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bottle, packaged in a) equate, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716, 2-0.5 FL OZ (15 mL) Bottles, 1 FL OZ (30 mL) TOTAL, UPC 6 81131 36701 1, NDC 49035-280-02; b) DG health, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; c) sunmark, Distributed By McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 62144 3, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; e) HealthMart, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 52569 13715 4; f) exchange select Artificial Tears, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; g) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, UPC 7 13733 29692 2, NDC 41250-718-01; h) H.E.B, MADE WITH PRIDE AND CARE FOR H.E.B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; i) GeriCare, Distributed by: Gericare Pharmaceuticals Corp., 1650 63rd St., Brooklyn, NY 11204, UPC 3 57896 18405 6, NDC 57896-181-05
by K.C. Pharmaceuticals, Inc
- Reason
- CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; b) Publix, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 01076 5; c) sterile eye drops, Original Formula, sunmark, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 16733 0, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; e) Eye Drops, Original Formula, GoodSense, Distributed By: Geiss, Destin & Dunn, Inc., Peachtree City, GA 30269, UPC 1 80410 00015 6, NDC 50804-141-01; f) sterile eye drops, Circle K, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404 Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; g) Sterile Eye Drops, Regular Formula, Lil Drug Store, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404; UPC 3 66715 68324 3; h) Tetrahydrozoline Ophthalmic Solution, Rugby, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, UPC 3 05361 21794 5, NDC 0536-1217-94, i) Leader, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, UPC 0 96295 13645 6, NDC 70000-0454-1; j) REDNESS RELIEF EYE DROPS, CAREone, Distributed by: FOODHOLD USA, LLC, LANDOVER, MD 20785; UPC 0 41520 86531 1, NDC 41520-431-05; k) Eye Drops, Original Formula, Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, UPC 0 87701 14975 7, NDC 24385-075-05; l) Eye Drops, ORIGINAL FORMULA, Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, UPC 3 11917 20076 7; m) CVS Health, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 36131 3; n) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; o) redness relief, Original Redness Reliever Eye Drops, meijer, DIST. BY MEIJER DISTRIBUTION INC., GRAND RAPIDS, MI 49544, UPC 0 41250 82916 4, NDC 41250-814-01; p) Eye Drops, ORIGINAL, Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47011 3
by K.C. Pharmaceuticals, Inc
- Reason
- CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass III
PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10,
by Vivus, Inc.
- Reason
- Failed Stability Specifications
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 2, 2024Historical recordClass III
SCREAMING EAGLE CO PACK LLC
- Product
- Tony Charchere's Ranch Salad Dressing packaged in 12oz PET b…
- Reason
- Bubbling of product and sour taste
- Published
- July 19, 2023
- Distribution
- Shipped to single distributor in LA
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 24, 2023Historical recordClass I
Dakota Style, Inc
- Product
- Gelson's Sea Salt Pretzels, 4.5oz poly bags, UPC: 23631-1118…
- Reason
- May contain undeclared milk
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 24, 2023Historical recordClass I
Dakota Style, Inc
- Product
- 1. Hy-Vee Dill Pickle Braided Pretzels, 10oz poly bags, UPC:…
- Reason
- May contain undeclared milk
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 24, 2023Historical recordClass I
Dakota Style, Inc
- Product
- 1. Hy-Vee Honey Mustard Braided Pretzels, 10oz poly bags, UP…
- Reason
- May contain undeclared milk
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 24, 2023Historical recordClass I
Dakota Style, Inc
- Product
- 1. Hy-Vee Salt & Vinegar Braided Pretzels, 10 oz poly bags,…
- Reason
- May contain undeclared milk
- Published
- July 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 16, 2023Historical recordClass I
Oregon Potato Company
- Product
- Rader Farms Organic Fresh Start Smoothie Blueberry, Strawber…
- Reason
- Potential contamination with Hepatitis A.
- Published
- July 19, 2023
- Distribution
- All products distributed in AR, AZ, CA,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 16, 2023Historical recordClass I
Oregon Potato Company
- Product
- Rader Farms Organic Berry Trio Strawberry, Blackberry, Raspb…
- Reason
- Potential contamination with Hepatitis A.
- Published
- July 19, 2023
- Distribution
- All products distributed in AR, AZ, CA,…
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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