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

11551–11575 of 17785

SevereFDA (Drugs)·D-1429-2016·2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate
PharMEDium Services, LLC is recalling 445 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), Rx Only, Compounded by…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1377-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate
PharMEDium Services, LLC is recalling 384 cassettes of Fentanyl Citrate and Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1362-2016·2016-07-27
PharMEDium Recalls Bupivacaine HCl Due to Glass Particulate Contamination
PharMEDium Services, LLC is recalling 2,194 bags and cassettes of 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride because the active pharmaceutical ingredient was contaminated with glass particulate matter.
Product
0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1371-2016·2016-07-27
PharMEDium Recalls Sufentanil and Bupivacaine Cassettes Due to Glass Particulates
PharMEDium Services is recalling 325 cassettes of compounded sufentanil and bupivacaine because the active ingredient was contaminated with glass particulate matter.
Product
0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2T8317, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-317-52
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1375-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services is recalling 1,527 bags of compounded fentanyl and bupivacaine injectable solution because glass particulate was found in the active pharmaceutical ingredient.
Product
1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1381-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate
Pharmedium Services is recalling specific lots of compounded fentanyl and bupivacaine syringes because the active ingredient was contaminated with glass particulate matter.
Product
10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only, Compounded by PharMEDium…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1389-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulates
PharMEDium Services is recalling 425 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of glass particulate matter.
Product
2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8103, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-103-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1360-2016·2016-07-27
Pharmedium Recalls Bupivacaine HCl Due to Glass Particulate Contamination
Pharmedium Services, LLC is recalling 177 cassettes of 0.03% Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-931-11
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1419-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
Pharmedium Services is recalling 3,828 syringes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.
Product
4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1367-2016·2016-07-27
PharMEDium Recalls Bupivacaine HCl Due to Glass Particulate Contamination
PharMEDium Services, LLC is recalling 355 bags of 0.2% Bupivacaine HCl sterile injectable drugs because the active ingredient was contaminated with glass particulate matter.
Product
0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1445-2016·2016-07-27
GlaxoSmithKline Recalls Bactroban Ointment Due to Penicillin Cross-Contamination
GlaxoSmithKline is recalling 18,000 tubes of Bactroban Ointment because of penicillin cross-contamination. The affected product is distributed nationwide and in Puerto Rico.
Product
Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1379-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
Pharmedium Services, LLC is recalling 750 bags of compounded Fentanyl Citrate and Bupivacaine HCl injectable solution distributed nationwide due to the presence of glass particulate matter.
Product
10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H9155, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 3614, NDC 61553-1552-52
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1442-2016·2016-07-27
GlaxoSmithKline Recalls Bactroban Cream Due to Penicillin Cross Contamination
GlaxoSmithKline is recalling Bactroban Cream (Mupirocin Calcium Cream 2%) due to penicillin cross contamination. The recall affects 28,131 tubes distributed nationwide and in Puerto Rico.
Product
Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-22,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1415-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 1,470 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of glass particulate matter.
Product
3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1398-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
Pharmedium Services, LLC is recalling 940 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1390-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 60 bags of compounded fentanyl and bupivacaine injectable solution nationwide because glass particulates were found in the active pharmaceutical ingredient.
Product
2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8095, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-095-50 ,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1374-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
Pharmedium Services, LLC is recalling 361 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9232, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-032-95
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1372-2016·2016-07-27
PharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulate
PharMEDium Services, LLC is recalling 866 bags of 0.5% Bupivacaine HCl injectable solution because the active ingredient was contaminated with glass particulate.
Product
0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1397-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulate
Pharmedium Services, LLC is recalling 250 bags of compounded Fentanyl Citrate and Bupivacaine HCl injectable solution because the active pharmaceutical ingredient was contaminated with glass particulate.
Product
2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K8433, NDC 61553-433-58, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1392-2016·2016-07-27
FDA Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulate
PharMEDium Services is recalling 950 bags of compounded fentanyl and bupivacaine infusions because glass particulate was found in the active pharmaceutical ingredient.
Product
2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), Rx Only, Compounded by…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1370-2016·2016-07-27
Pharmedium Recalls Sufentanil and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services, LLC is recalling 10 bags of compounded sufentanil and bupivacaine solution because the active ingredient was contaminated with glass particulate matter.
Product
0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8577, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-577-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1418-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 455 bags of compounded fentanyl and bupivacaine injectable solutions distributed nationwide. The recall is due to the presence of glass particulate matter in the active pharmaceutical ingredient.
Product
4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1427-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulates
PharMEDium Services is recalling 45 cassettes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.
Product
5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, Service Code 2T8200, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-200-52
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1393-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services is recalling 1,476 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of glass particulate matter.
Product
2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8296 (NDC 61553-296-52), 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8296 (NDC 61553-296-22), Rx Only, Compounded by…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1361-2016·2016-07-27
PharMEDium Recalls Morphine and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 80 bags of compounded morphine and bupivacaine injectable solution due to the presence of glass particulate matter.
Product
0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-995-54 ,
Category
Drug
Distribution
Distributed nationwide

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11551–11575 of 17785