Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

12501–12525 of 18028

HighFDA (Drugs)·D-0655-2016·2016-02-17
Fagron Recalls SyrSpend SF Grape Flavor Due to Yeast Contamination
Fagron, Inc. is recalling SyrSpend SF Grape Flavor suspending base due to the presence of yeast. The recall affects 148 bottles distributed nationwide.
Product
SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0661-2016·2016-02-17
Safecor Health Recalls Haloperidol Oral Solution Due to Leaking Bottles
Safecor Health is recalling 3,532 bottles of Haloperidol Oral Solution because customer complaints confirmed the bottles were leaking.
Product
Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0656-2016·2016-02-17
Fagron Recalls SyrSpend SF Suspending Base Due to Yeast Contamination
Fagron, Inc. is recalling SyrSpend SF Suspending Base because the product contains yeast. The recall covers 88 bottles distributed nationwide.
Product
SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-9.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0659-2016·2016-02-17
Sandoz Recalls Candesartan Cilexetil Tablets Due to Impurity Failures
Sandoz Inc. is recalling Candesartan Cilexetil Tablets, 16 mg, because the product failed impurities and degradation specifications at a 9-month stability timepoint.
Product
Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0657-2016·2016-02-17
Safecor Recalls Midazolam Syrup Cups Due to Cardboard Contaminant
Safecor Health is recalling specific lots of Midazolam HCl Syrup unit dose cups found to contain a small piece of cardboard.
Product
Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0654-2016·2016-02-17
Fagron Recalls SyrSpend SF Syrup Due to Yeast Contamination
Fagron, Inc. is recalling SyrSpend SF syrup-suspending vehicle due to the presence of yeast. The recall affects 44 bottles distributed nationwide.
Product
SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0660-2016·2016-02-17
Amerisource Recalls Candesartan Cilexetil Tablets Due to Impurity Failures
Amerisource Health Services is recalling 716 cartons of Candesartan Cilexetil Tablets, 16 mg, due to failed impurities and degradation specifications.
Product
Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0652-2016·2016-02-10
Perrigo Recalls Nystatin Powder for Labeling Error on Declared Strength
Perrigo is recalling 918 units of Nystatin USP Powder due to a labeling error regarding the declared strength. The product was distributed nationwide.
Product
Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0649-2016·2016-02-10
Pfizer Recalls Lyrica Pregabalin Capsules for Deformed or Damaged Units
Pfizer is recalling specific lots of Lyrica (pregabalin) 75 mg capsules due to the potential presence of deformed or damaged capsules.
Product
LYRICA — LYRICA (PREGABALIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0648-2016·2016-02-10
Pfizer Recalls Lyrica Capsules Due to Deformed or Damaged Shells
Pfizer is recalling specific lots of Lyrica (pregabalin) 50 mg capsules due to the potential presence of deformed or damaged capsules.
Product
LYRICA — LYRICA (PREGABALIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0651-2016·2016-02-10
Perrigo Recalls Nystatin Powder for Labeling Error on Declared Strength
Perrigo Company PLC is recalling Nystatin, USP Powder for Rx compounding due to a labeling error regarding the declared strength.
Product
Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0650-2016·2016-02-10
Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure
Mylan Institutional, Inc. is recalling Clonazepam Tablets, 0.5 mg, because a known impurity exceeded specifications at the 6-month timepoint.
Product
Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0632-2016·2016-02-03
Sentara Recalls Penicillin in D5W Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Penicillin in D5W Homepumps because the sterility of the product cannot be guaranteed.
Product
PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0638-2016·2016-02-03
Sentara Recalls AZACTAM Bags Due to Sterility Assurance Concerns
Sentara Enterprises is recalling 12 bags of AZACTAM (aztreonam) 2GM in NS because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.
Product
AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0620-2016·2016-02-03
Sentara Recalls Dextrose-NaCl Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Dextrose-NaCl (D5-1/2NS) in Homepumps because product sterility cannot be guaranteed.
Product
Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0612-2016·2016-02-03
Sentara Recalls Daptomycin Syringes Due to Sterility Assurance Concerns
Sentara Enterprises is recalling specific lots of CUBICIN (daptomycin) in NS syringes and homepumps because the sterility of the product cannot be guaranteed.
Product
CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML Syringes, c) 380MG in 7.6ML Syringes, d) 400MG in 8ML Syringes, e) 460MG in 9.2ML Syringes, f) 475MG in 9.5ML Syringes, g) 500MG in 10ML Syringes, h) 580MG in 116ML Homepumps, i) 600MG in 120ML…
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0630-2016·2016-02-03
Sentara Recalls ZOSYN Homepumps Due to Sterility Assurance Concerns
Sentara Enterprises is recalling specific lots of ZOSYN (piperacillin/tazobactam) homepumps because product sterility cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.
Product
ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300…
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0626-2016·2016-02-03
Sentara Recalls Ganciclovir Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Ganciclovir in NS Homepumps because product sterility cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.
Product
GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0611-2016·2016-02-03
Sentara Recalls Meropenem Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling Meropenem in NS Homepumps because product sterility cannot be guaranteed. The recall affects 192 bags distributed in Virginia and North Carolina.
Product
MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0637-2016·2016-02-03
Sentara Recalls Compounded Cancidas Due to Sterility Concerns
Sentara Enterprises is recalling 7 bags of compounded Cancidas (caspofungin acetate) because the sterility of the product cannot be guaranteed.
Product
Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0614-2016·2016-02-03
Sentara Parenteral Amino Acid Infusion Recalled for Sterility Concerns
Sentara Enterprises is recalling Parenteral Amino Acid Infusion 10% bags because product sterility cannot be guaranteed. The recall affects specific lots compounded in September 2015.
Product
Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps…
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0617-2016·2016-02-03
Sentara Recalls Solumedrol Bags Due to Sterility Assurance Concerns
Sentara Enterprises is recalling 7 bags of Solumedrol (methylprednisolone succinate) 1GM in NS because product sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.
Product
SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0628-2016·2016-02-03
Sentara Recalls Invanz Injection Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Invanz (ertapenem) injection homepumps because product sterility cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.
Product
Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0592-2016·2016-02-03
Pharmakon Recalls Succinylcholine Syringes Due to Stability Data Concerns
Pharmakon Pharmaceuticals is recalling 2,750 syringes of Succinylcholine 20 mg/mL because stability data does not support the expiration dates.
Product
Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0625-2016·2016-02-03
Sentara Recalls Hydromorphone HCL Due to Sterility Assurance Concerns
Sentara Enterprises is recalling specific lots of Hydromorphone HCL because the sterility of the product cannot be guaranteed.
Product
HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e) 135MG in 135ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states

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