Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Product Mix-up
Is Hydrocodone recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Hydrocodone (22 total). Check the affected lots below.
Most common reason: Wrong potency / content (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydrocodone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Hydrocodone recalls on record
none so far in 2026; 22 on record, newest first
Class III · Low risk
Hydrocodone Bitartrate and Homatropine Methlybromide tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Class II · Moderate risk
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Class II · Moderate risk
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Class II · Moderate risk
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Labeling: Missing Label
Class III · Low risk
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
NORCO (Hydrocodone Bitartrate and Acetaminophen)
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets USP
Failed Tablet/Capsule Specifications; Product contains broken tablets.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.
Class II · Moderate risk
HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet
Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: W003999, EXP: 7/1/2014.
Class I · High risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Class I · High risk
Hydrocodone bitartrate and acetaminophen Tablets
Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Class I · High risk
Hydrocodone Bitartrate and Acetaminophen Tablets USP
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Class I · High risk
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Class II · Moderate risk
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Impurities/Degradation Products: exceeded specification at 3 month stability testing
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.