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 deaths or serious injuries are reported, 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

10526–10550 of 17785

SevereFDA (Drugs)·D-0890-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 22 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,666 pellets distributed nationwide.
Product
Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0888-2017·2017-06-14
MedPark Pharmacy Recalls Methylcobalamin Injection Vials Due to Sterility Concerns
MedPark Pharmacy is recalling methylcobalamin 1mg/1mL injection vials because the company cannot ensure the product is sterile. The affected lot was distributed to a patient in Maryland.
Product
methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0892-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 18 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 6,361 pellets distributed nationwide.
Product
Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0885-2017·2017-06-14
Dr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures
Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications, potentially affecting drug absorption.
Product
ZENATANE — ZENATANE (ISOTRETINOIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0881-2017·2017-06-14
Spectrum Laboratory Estradiol API Recalled for CGMP Deviations
Spectrum Laboratory Products is recalling Estradiol active pharmaceutical ingredient due to Good Manufacturing Practice deviations found during an FDA inspection.
Product
Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Pr
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0896-2017·2017-06-14
Qualgen Estradiol Pellets Recalled for Quality Assurance Deviations
Qualgen is recalling Estradiol 6 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,815 pellets distributed nationwide.
Product
Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by; Qualgen 14844 Bristol Park Blvd. Edmond, OK 73013 NDC: 69761-006-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0889-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 25 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,153 pellets distributed nationwide.
Product
Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0883-2017·2017-06-14
Dr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures
Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications, potentially affecting drug absorption.
Product
ZENATANE — ZENATANE (ISOTRETINOIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0891-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 20 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,468 pellets distributed nationwide.
Product
Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0886-2017·2017-06-14
Dr. Reddy's Recalls Zenatane Capsules for Low Dissolution
Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications.
Product
ZENATANE — ZENATANE (ISOTRETINOIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0893-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 15 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 6,227 units distributed nationwide.
Product
Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0887-2017·2017-06-14
Perrigo Recalls Option 2 Emergency Contraceptive Tablets Due to Missing Blister
L. Perrigo Company is recalling Option 2 emergency contraceptive tablets because some cartons are missing the tablet blister strip and tablet.
Product
OPTION 2 — OPTION 2 (LEVONORGESTREL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0884-2017·2017-06-14
Dr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failure
Dr. Reddy's is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications, potentially affecting drug absorption.
Product
ZENATANE — ZENATANE (ISOTRETINOIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0895-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 10 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 5,260 pellets distributed nationwide.
Product
Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-010-01
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0897-2017·2017-06-14
Hetero USA Recalls Acyclovir Tablets Due to Human Hair Presence
Hetero USA Inc. is recalling 13,692 bottles of Acyclovir 800 mg tablets because human hair was found melded into the tablets.
Product
ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0877-2017·2017-06-07
SCA Pharmaceuticals Recalls Cefazolin Sodium Bags Due to Leaking
SCA Pharmaceuticals is recalling 70 bags of cefazolin sodium due to leaks at the seam, which compromises the product's sterility.
Product
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0875-2017·2017-06-07
SCA Pharmaceuticals Recalls Hydrocodone Injectable Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 87 bags of Hydromorphone HCL injectable solution because the bags are leaking at the seam, compromising sterility.
Product
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0874-2017·2017-06-07
SCA Pharmaceuticals Recalls Fentanyl Injectable Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling fentanyl citrate injectable bags because they are leaking at the seam, which compromises sterility.
Product
fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0872-2017·2017-06-07
SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Seam Leaks
SCA Pharmaceuticals is recalling 118 bags of fentanyl injection due to seam leaks that compromise sterility. The product was distributed nationwide in the USA.
Product
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0873-2017·2017-06-07
SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 370 bags of fentanyl injection solution because the bags were leaking at the seam, compromising sterility.
Product
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0876-2017·2017-06-07
SCA Pharmaceuticals Recalls Leaking Cefazolin Sodium Injectable Bags
SCA Pharmaceuticals is recalling 240 bags of cefazolin sodium injectable due to seam leaks that compromise sterility.
Product
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0871-2017·2017-06-07
SCA Pharmaceuticals Recalls Morphine Sulfate Injectable Bags Due to Leaking
SCA Pharmaceuticals is recalling 56 bags of morphine sulfate in 0.9% Sodium Chloride injectable because the bags are leaking at the seam, compromising sterility.
Product
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-55
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0878-2017·2017-06-07
SCA Pharmaceuticals Recalls Leaking Magnesium Sulfate Injectable Bags
SCA Pharmaceuticals is recalling 40 bags of Magnesium Sulfate injectable solution due to seam leaks that compromise sterility.
Product
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0879-2017·2017-06-07
SCA Pharmaceuticals Recalls Phenylephrine Injectable Bags Due to Leaking
SCA Pharmaceuticals is recalling 30 bags of Phenylephrine HCL injectable solution because the bags are leaking at the seam, compromising sterility.
Product
PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0870-2017·2017-06-07
SCA Pharmaceuticals Recalls Morphine Sulfate Injectable Bags Due to Leaking
SCA Pharmaceuticals is recalling 80 bags of morphine sulfate injectable solution because the bags are leaking at the seam, compromising sterility.
Product
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.
Category
Drug
Distribution
Distributed nationwide

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10526–10550 of 17785