FDA Recall
TerminatedTerminated: December 29, 2015Historical recordClass II
GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540
by Micro Labs Usa, Inc S
- Reason
- Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
- Published
- November 5, 2014
- Distribution
- Multiple states
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FDA Recall
TerminatedTerminated: March 23, 2017Historical recordClass II
Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Forest, IL 60045; Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618; and b) 1 mL Single-dose Vial, packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0409-2634-01), Hospira, Inc., Lake Forest, IL 60045.
by Hospira Inc.
- Reason
- Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
- Published
- October 29, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 1, 2015Historical recordClass III
MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11
by American Health Packaging
- Reason
- Subpotent; 6 month stability time point
- Published
- October 29, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 6, 2014Historical recordClass II
Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India
by Aidarex Pharmaceuticals LLC
- Reason
- Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
- Published
- October 29, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 24, 2015Historical recordClass II
ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528
by Zee Medical Products Inc
- Reason
- Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.
- Published
- October 29, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 2, 2016Historical recordClass II
CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0843-54, OTC
by Qualitest Pharmaceuticals
- Reason
- Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
- Published
- October 29, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 2, 2016Historical recordClass II
CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0842-54, OTC
by Qualitest Pharmaceuticals
- Reason
- Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
- Published
- October 29, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 2, 2016Historical recordClass II
CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC
by Qualitest Pharmaceuticals
- Reason
- Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
- Published
- October 29, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 29, 2017Historical recordClass II
Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07
by Forest Pharmaceuticals Inc
- Reason
- Failed Dissolution Specification; at the 6-month stability time point
- Published
- October 29, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 4, 2018Historical recordClass II
Rector's Remedy OINTMENT, Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
by New Gpc Inc.
- Reason
- Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing and lack of OTC drug labeling requirements.
- Published
- October 29, 2014
- Distribution
- New York
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FDA Recall
TerminatedTerminated: June 4, 2018Historical recordClass II
Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
by New Gpc Inc.
- Reason
- Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.
- Published
- October 29, 2014
- Distribution
- New York
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FDA Recall
TerminatedTerminated: June 4, 2018Historical recordClass II
WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
by New Gpc Inc.
- Reason
- Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
- Published
- October 29, 2014
- Distribution
- New York
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FDA Recall
TerminatedTerminated: June 4, 2018Historical recordClass II
Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
by New Gpc Inc.
- Reason
- Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
- Published
- October 29, 2014
- Distribution
- New York
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FDA Recall
TerminatedTerminated: June 4, 2018Historical recordClass II
MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana.
by New Gpc Inc.
- Reason
- Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
- Published
- October 29, 2014
- Distribution
- New York
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FDA Recall
TerminatedTerminated: June 4, 2018Historical recordClass II
alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product packaged within a glass container individually placed in small carton. Country of Origin Guyana.
by New Gpc Inc.
- Reason
- Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
- Published
- October 29, 2014
- Distribution
- New York
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FDA Recall
TerminatedTerminated: June 4, 2018Historical recordClass II
alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a plastic container individually placed in small carton. Country of Origin Guyana.
by New Gpc Inc.
- Reason
- Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
- Published
- October 29, 2014
- Distribution
- New York
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FDA Recall
TerminatedTerminated: August 10, 2015Historical recordClass II
Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC, Distributed by: Rugby Laboratories Livonia, MI 48150, NDC 0536-3606-96 Major Children's Mapap Suspension Liquid, Cherry Flavor, 4 FL OZ bottle, OTC, Distributed by: Major Pharmaceuticals Livonia, MI 48150 , NDC 0904-6308-20,
by Bio-pharm, Inc.
- Reason
- Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint.
- Published
- October 29, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 23, 2016Historical recordClass II
Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195
by Sagent Pharmaceuticals Inc
- Reason
- Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
- Published
- October 22, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 3, 2015Historical recordClass III
Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15
by Valeant Pharmaceuticals International
- Reason
- Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
- Published
- October 22, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 3, 2015Historical recordClass III
Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15
by Valeant Pharmaceuticals International
- Reason
- Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
- Published
- October 22, 2014
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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