Recall archive
54 recalls · page 2 of 3
Reported May 1, 2019
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn Inc.
Matched: Brand · Product details — Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
FDA (openFDA drug enforcement)
Reported Apr 10, 2019
Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc.,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand — Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
FDA (openFDA drug enforcement)
Reported Mar 20, 2019
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified…
FDA (openFDA drug enforcement)
Reported Feb 20, 2019
COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn Inc.
Matched: Brand · Product details — Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
FDA (openFDA drug enforcement)
Reported Feb 6, 2019
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product · Product details — Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
FDA (openFDA drug enforcement)
Reported Dec 5, 2018
Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only.…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand — Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
FDA (openFDA drug enforcement)
Reported Sep 12, 2018
Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand — Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
FDA (openFDA drug enforcement)
Reported Sep 5, 2018
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
FDA (openFDA drug enforcement)
Reported Aug 15, 2018
Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand — Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12…
FDA (openFDA drug enforcement)
Reported Jul 18, 2018
Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product · Product details — CGMP Deviations
FDA (openFDA drug enforcement)
Reported Apr 4, 2018
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand — Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Mar 28, 2018
Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand — Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
FDA (openFDA drug enforcement)
Reported Mar 14, 2018
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand · Product · Product details — Failed Stability Specification: OOS low viscosity results discovered during retain testing.
FDA (openFDA drug enforcement)
Reported May 17, 2017
IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand · Product details — Product is being recalled due to low pH value.
FDA (openFDA drug enforcement)
Reported Apr 19, 2017
LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product · Product details — Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
FDA (openFDA drug enforcement)
Reported Nov 9, 2016
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn Inc.
Matched: Brand · Product · Product details — Subpotent Drug: concentration of product is less than labeled amount.
FDA (openFDA drug enforcement)
Reported Aug 31, 2016
Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand — Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
FDA (openFDA drug enforcement)
Reported Jun 8, 2016
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product · Product details — Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
FDA (openFDA drug enforcement)
Reported Jun 1, 2016
ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand — Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported May 11, 2016
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand — Presence of Particulate Matter
FDA (openFDA drug enforcement)
Reported Nov 25, 2015
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand · Product · Product details — Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Sep 23, 2015
IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand · Product details — Subpotent Drug: Low out-of-specification potency result of the drug product.
FDA (openFDA drug enforcement)
Reported Jun 17, 2015
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand — Failed Impurities/Degradation Specifications
1 more product in this recall
FDA (openFDA drug enforcement)
Reported May 20, 2015
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand — Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
2 more products in this recall
FDA (openFDA drug enforcement)
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