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

17476–17500 of 17807

ModerateFDA (Drugs)·D-006-2013·2012-10-17
Actavis Recalls Prometh VC with Codeine Cough Syrup Due to Stability Issues
Actavis Mid Atlantic LLC is recalling Prometh VC with Codeine Cough Syrup because specific lots do not meet room temperature stability specifications for an unknown degradant.
Product
Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-007-2013·2012-10-17
Paddock Recalls Moexipril HCl Tablets Due to Dissolution Failure
Paddock Laboratories is recalling one lot of Moexipril HCl Tablets 7.5mg due to a dissolution failure found during routine stability testing.
Product
Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-005-2013·2012-10-17
Actavis Recalls Prometh VC Plain Due to Unknown Degradant
Actavis Mid Atlantic LLC is recalling Prometh VC Plain bottles because they do not meet stability specifications for an unknown degradant.
Product
Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-003-2013·2012-10-10
Caraco Recalls Nimodipine Capsules Due to Crystallization
Caraco Pharmaceutical Laboratories is recalling Nimodipine Capsules 30 mg because crystals of the drug were found within the capsule solution.
Product
Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical…
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-001-2013·2012-10-10
McKesson Recalls bupropion Hydrochloride Extended-Release Tablets Due to Dissolution Failure
McKesson Packaging Services is recalling 187 cartons of bupropion Hydrochloride Extended-Release Tablets, 150 mg, because they failed USP dissolution test requirements.
Product
buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-002-2013·2012-10-10
McKesson Recalls bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures
McKesson Packaging Services is recalling bupropion hydrochloride extended-release tablets because they failed USP dissolution test requirements.
Product
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1703-2012·2012-10-10
Mylan Recalls Famotidine Tablets Due to Out-of-Specification Impurities
Mylan Pharmaceuticals is recalling 31,867 bottles of Famotidine Tablets USP, 20 mg, due to out-of-specification results for related compounds found during routine stability testing.
Product
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1698-2012·2012-10-03
FDA Recalls Hard Ten Days Capsules for Unapproved Sildenafil
The FDA is recalling Hard Ten Days Capsules because they contain sildenafil, an unapproved active ingredient. Consumers should stop using the product.
Product
Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1700-2012·2012-10-03
Japan Weight Loss Blue Capsules Recalled for Unapproved Sibutramine
Vitaminbestbuy.com is recalling Japan Weight Loss Blue Capsules because they contain sibutramine, an unapproved drug ingredient.
Product
Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1686-2012·2012-10-03
Baxter Recalls 5% Dextrose Injection Due to Chemical Contamination
Baxter Healthcare is recalling 5% Dextrose Injection USP in AVIVA containers due to potential trace levels of cumene hydroperoxide.
Product
5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1697-2012·2012-10-03
Ben Venue Recalls Vecuronium Bromide Injection Due to Particulate Matter
Ben Venue Laboratories is recalling Vecuronium Bromide for Injection due to the presence of particulate matter.
Product
Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1689-2012·2012-10-03
Baxter Recalls 0.9% Sodium Chloride Injection Due to Chemical Contamination
Baxter Healthcare is recalling 0.9% Sodium Chloride Injection USP in AVIVA containers due to potential trace levels of cumene hydroperoxide.
Product
0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1702-2012·2012-10-03
Mylan Recalls Levetiracetam Tablets Due to Foreign Tablet Presence
Mylan Pharmaceuticals is recalling 960 bottles of Levetiracetam 500 mg tablets because foreign tablets may have been distributed in the bottles.
Product
LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1699-2012·2012-10-03
Man King Capsules Recalled for Unapproved Sildenafil Presence
The FDA is recalling Man King Capsules because they contain sildenafil, an unapproved active ingredient. Consumers should stop using the product.
Product
Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., 27 Heping Road, Haikou, Henan Province, UPC 9 009900 0032328
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1693-2012·2012-10-03
Actavis Recalls Fentanyl Transdermal Systems Due to Subpotent Product
Actavis is recalling Fentanyl Transdermal Systems, 100 mcg/h, because some patches may not contain fentanyl gel. The recall covers 98,088 cartons distributed nationwide.
Product
Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1688-2012·2012-10-03
Baxter Recalls 5% Dextrose and 0.45% Sodium Chloride Injection Due to Chemical Contamination
Baxter Healthcare is recalling 5,064 containers of 5% Dextrose and 0.45% Sodium Chloride Injection USP due to potential trace levels of cumene hydroperoxide.
Product
5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1695-2012·2012-10-03
Abbott Recalls Synthroid Tablets Due to Container Wall Defect
Abbott Laboratories is recalling 42,596 bottles of Synthroid (levothyroxine sodium) 75 mcg tablets due to a localized thin wall defect on the bottle bottom that may impact tablet stability.
Product
SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1696-2012·2012-10-03
Abbott Recalls Synthroid Tablets Due to Defective Bottle Bottoms
Abbott Laboratories is recalling 40,464 bottles of Synthroid (levothyroxine sodium) 112 mcg tablets nationwide. The recall addresses a localized thin wall defect on the bottom of some bottles that may impact tablet stability.
Product
SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1687-2012·2012-10-03
Baxter Recalls 10% Dextrose Injection Due to Chemical Contamination
Baxter Healthcare is recalling 2,976 containers of 10% Dextrose Injection USP due to potential trace levels of cumene hydroperoxide.
Product
10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1691-2012·2012-10-03
Dispensing Solutions Recalls Atrovent HFA Inhalers Due to Label Error
Dispensing Solutions, Inc. is recalling 18 Atrovent HFA inhalers because a sticker label incorrectly identifies the product as Ventolin HFA.
Product
Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-1690-2012·2012-10-03
Baxter Recalls Lactated Ringer's Injection Due to Chemical Contamination
Baxter Healthcare is recalling specific lots of Lactated Ringer's Injection USP due to potential trace levels of cumene hydroperoxide.
Product
Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1694-2012·2012-10-03
Abbott Recalls Synthroid Tablets Due to Defective Bottle Bottoms
Abbott Laboratories is recalling 53,448 bottles of Synthroid (levothyroxine sodium) 50 mcg tablets nationwide due to a defect in the bottle bottom that may affect tablet stability.
Product
SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1701-2012·2012-10-03
Glenmark Recalls Naproxen Sodium Tablets Due to Labeling Error
Glenmark Generics is recalling Naproxen Sodium 500 mg tablets because some bottles may contain Pravastatin Sodium 40 mg tablets.
Product
NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1685-2012·2012-10-03
Hospira Recalls Propofol Injectable Emulsion Due to Particulate Matter
Hospira Inc. is recalling 148,630 vials of Propofol Injectable Emulsion because a single visible particulate was found in sample bottles during inspection.
Product
PROPOFOL — PROPOFOL (PROPOFOL)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1692-2012·2012-10-03
Mallinckrodt Recalls Thallous Chloride Tl 201 Injection Due to Labeling Mismatch
Mallinckrodt Inc. is recalling specific lots of Thallous Chloride Tl 201 Injection because outer container labels do not match the vial labels.
Product
Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of…
Category
Drug
Distribution
11 states

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17476–17500 of 17807