Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber…
Reason Product Mix-up
Is Hydrocodone recalled?
23 FDA recalls mention Hydrocodone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydrocodone.
Class III · Low risk Terminated
Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown…
Reason Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability…
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber…
Reason Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium…
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by…
Reason Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Class II · Moderate risk Terminated
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate…
Reason Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine…
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle…
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle…
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class III · Low risk Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel…
Reason Labeling: Missing Label
Class III · Low risk Terminated
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan…
Reason Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Class III · Low risk Terminated
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only…
Reason Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case…
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson…
Reason Failed Tablet/Capsule Specifications; Product contains broken tablets.
Class III · Low risk Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories…
Reason Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the…
Class II · Moderate risk Terminated
HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52544016201
Reason Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC…
Class I · High risk Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered…
Reason Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Class I · High risk Terminated
Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b)…
Reason Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Class I · High risk Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By…
Reason Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Class I · High risk Ongoing
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST…
Reason Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone…
Class II · Moderate risk Terminated
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per…
Reason Impurities/Degradation Products: exceeded specification at 3 month stability testing
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt…
Reason CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
Class III · Low risk Terminated
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt…
Reason Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
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