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

14801–14825 of 18001

SevereFDA (Drugs)·D-0048-2015·2014-11-05
Hi-Tech Pharmacal Recalls HydrOXYzine Hydrochloride Oral Solution Due to Impurity
Hi-Tech Pharmacal Co., Inc. is recalling 451,916 bottles of HydrOXYzine Hydrochloride Oral Solution because an unknown impurity exceeded specifications during stability testing.
Product
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0142-2015·2014-11-05
Martin Avenue Pharmacy Recalls Tobramycin Eye Drops for Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tobramycin eye drops due to quality control issues that may compromise sterility.
Product
Tobramycin (PF) 15 mg/mL opthalmic solution packaged in opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0050-2015·2014-11-05
Teva Recalls Dextroamphetamine Tablets Due to Unknown Impurities
Teva Pharmaceuticals is recalling specific lots of dextroamphetamine tablets because they failed impurity specifications. The recall covers 19,545 bottles distributed nationwide.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0075-2015·2014-11-05
Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including cyclosporine/corn oil, due to quality control observations that risk sterility assurance.
Product
Cyclosporine/corn oil stock vehicle oil packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0233-2015·2014-11-05
Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide
Actavis Inc. is voluntarily recalling 46,676 cartons of Vancomycin Hydrochloride Capsules, USP, 250 mg, because the drug is subpotent.
Product
Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3561-15 UPC 3-3-0591356115-1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0056-2015·2014-11-05
Martin Avenue Pharmacy Recalls Acetylcysteine Eye Drops Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Acetylcysteine 10% ophthalmic solution due to quality control issues that may compromise sterility.
Product
Acetylcysteine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0231-2015·2014-11-05
Specialty Compounding Recalls All Prescription Products Due to Sterility Concerns
Specialty Compounding, LLC is recalling all prescription products manufactured by the company due to a lack of assurance of sterility.
Product
All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0157-2015·2014-11-05
Martin Avenue Pharmacy Recalls Tri-mix ST5 Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST5 injectable vials due to quality control observations that present a risk to sterility assurance.
Product
Tri-mix ST5, 30 mg/1.5 mg/300 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0146-2015·2014-11-05
Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.
Product
Tri-mix, 12 mg/1 mg/9 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0107-2015·2014-11-05
Martin Avenue Pharmacy Recalls Compounded Injectable Preparations for Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile injectable preparations due to quality control observations that risk sterility assurance.
Product
"NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL (phentolamine mesylate, papaverine, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0122-2015·2014-11-05
Martin Avenue Pharmacy Recalls Polyhexamethylene Biguanide Eye Drops
Martin Avenue Pharmacy is voluntarily recalling compounded polyhexamethylene biguanide eye drops due to quality control issues that risk sterility assurance.
Product
Polyhexamethylene biguanide 0.02% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0160-2015·2014-11-05
Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.
Product
Tri-mix ST9-E, 30 mg/4 mg/150 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0112-2015·2014-11-05
Martin Avenue Pharmacy Recalls PGE 2 Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling PGE 2 injectable vials due to quality control issues affecting sterility assurance.
Product
PGE 2, 100 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0120-2015·2014-11-05
Martin Avenue Pharmacy Recalls Phenylephrine 10% Ophthalmic Solution
Martin Avenue Pharmacy is voluntarily recalling Phenylephrine 10% ophthalmic solution due to quality control issues that risk sterility assurance.
Product
Phenylephrine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0154-2015·2014-11-05
Martin Avenue Pharmacy Recalls Tri-mix SEST 4 Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix SEST 4 injectable vials due to quality control observations that present a risk to sterility assurance.
Product
Tri-mix SEST 4, 30 mg/1.5 mg/400 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0076-2015·2014-11-05
Martin Avenue Pharmacy Recalls Dexamethasone Sodium Phosphate Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Dexamethasone sodium phosphate 4 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.
Product
Dexamethasone sodium phosphate 4 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0123-2015·2014-11-05
Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Polyhexamethylene biguanide 2% stock solution, due to quality control issues affecting sterility assurance.
Product
Polyhexamethylene biguanide 2% stock solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0072-2015·2014-11-05
Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including cyanocobalamin, due to quality control observations that risk sterility assurance.
Product
Cyanocobalamin 1000 mcg/mL injectable solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0117-2015·2014-11-05
Martin Avenue Pharmacy Recalls Phenol 10% Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Phenol 10% injectable vials due to quality control observations that present a risk to sterility assurance.
Product
Phenol 10% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0066-2015·2014-11-05
Martin Avenue Pharmacy Recalls Cefazolin Ophthalmic Solution for Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Cefazolin ophthalmic solution due to quality control issues that may compromise sterility.
Product
Cefazolin forte 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0080-2015·2014-11-05
Martin Avenue Pharmacy Recalls Fentanyl Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling fentanyl injectable syringes due to quality control issues that may compromise sterility assurance.
Product
Fentanyl injectable 2000 mcg/mL packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0054-2015·2014-11-05
Martin Avenue Pharmacy Recalls Acetylcysteine Inhalant Solution Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Acetylcysteine 10% inhalant solution due to quality control observations that present a risk to sterility assurance.
Product
Acetylcysteine 10% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0064-2015·2014-11-05
Martin Avenue Pharmacy Recalls Bupivacaine Hydrochloride Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Bupivacaine hydrochloride 0.25% injectable vials due to quality control observations that present a risk to sterility assurance.
Product
Bupivacaine hydrochloride 0.25% injectable packaged in an amber glass injectable vial,Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0162-2015·2014-11-05
Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix T102 injectable vials because quality control issues identified during an FDA inspection may compromise sterility.
Product
Tri-mix T102, 17.65 mg/0.59 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0136-2015·2014-11-05
Martin Avenue Pharmacy Recalls Sodium Tetradecyl Sulfate Injectable
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations due to quality control observations that present a risk to sterility assurance.
Product
Sodium tetradecyl sulfate 5% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide

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14801–14825 of 18001