FDA Recall
TerminatedTerminated: August 4, 2022Historical recordClass II
Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11
by American Health Packaging
- Reason
- Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
- Published
- February 19, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 17, 2022Historical recordClass II
Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20
by AuroMedics Pharma LLC
- Reason
- Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
- Published
- February 19, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 22, 2020Historical recordClass II
New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5
by Efficient Laboratories, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- February 19, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 22, 2020Historical recordClass II
Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1
by Efficient Laboratories, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- February 19, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 22, 2020Historical recordClass II
Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8
by Efficient Laboratories, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- February 19, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 17, 2020Historical recordClass III
Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34.
by Par Pharmaceutical Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
- Published
- February 19, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 8, 2021Historical recordClass II
Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30.
by Pfizer Inc.
- Reason
- Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
- Published
- February 19, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 8, 2021Historical recordClass II
Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30.
by Pfizer Inc.
- Reason
- Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
- Published
- February 19, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 29, 2022Historical recordClass II
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
by Akorn Inc
- Reason
- Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
- Published
- February 19, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 3, 2020Historical recordClass II
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01
by Teva Pharmaceuticals USA
- Reason
- CGMP deviations: Product bottle may be absent of desiccant.
- Published
- February 19, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 3, 2020Historical recordClass II
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01
by Teva Pharmaceuticals USA
- Reason
- CGMP deviations: Product bottle may be absent of desiccant.
- Published
- February 19, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass II
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).
by Pfizer Inc.
- Reason
- Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
- Published
- February 19, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 26, 2021Historical recordClass II
Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01.
by Zydus Pharmaceuticals USA Inc
- Reason
- cGMP Deviations
- Published
- February 19, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 23, 2024Historical recordClass I
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
- Published
- February 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass II
Sugar Foods Corporation
- Product
- Granulate Pure Cane Sugar sold under the brand names of:…
- Reason
- They were notified by their supplier that the product may be contaminated with foreign material.
- Published
- February 19, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 28, 2020Historical recordClass I
Adm Milling
- Product
- Bulk flour
- Reason
- E.coli O26
- Published
- February 19, 2020
- Distribution
- AR CT FL IL IN MA MD MI NJ NY…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 28, 2020Historical recordClass I
Adm Milling
- Product
- Springup Flour Product Code 703220 in 50# bags
- Reason
- E.coli O26
- Published
- February 19, 2020
- Distribution
- AR CT FL IL IN MA MD MI NJ NY…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 28, 2020Historical recordClass I
Adm Milling
- Product
- Sir Lancelot HG Flour Unbl, Enr, Mt / Product Code: 802203…
- Reason
- E.coli O26
- Published
- February 19, 2020
- Distribution
- AR CT FL IL IN MA MD MI NJ NY…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 28, 2020Historical recordClass I
Adm Milling
- Product
- Sir Galahad flour / Product Code: 805226 in 50# bags
- Reason
- E.coli O26
- Published
- February 19, 2020
- Distribution
- AR CT FL IL IN MA MD MI NJ NY…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 28, 2020Historical recordClass I
Adm Milling
- Product
- Potentate flour / Prod Code: 802217 in 50# bags
- Reason
- E.coli O26
- Published
- February 19, 2020
- Distribution
- AR CT FL IL IN MA MD MI NJ NY…
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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