Class I · High risk
Hydrocodone Bitartrate and Acetaminophen Tablets USP
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Pain Relief & OTC Medication Recalls
Recalls of common over-the-counter and prescription pain relievers.
415 recalls in this category, newest first.
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
OFIRMEV (acetaminophen)
Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
Class II · Moderate risk
Walgreens ASPIRIN FREE TENSION HEADACHE
Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.
Class III · Low risk
Major brand Infants' Mapap
Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014
Class II · Moderate risk
Naproxen Tablets USP
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
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
Diclofenac Sodium
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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.
Class III · Low risk
Endocet (oxycodone and acetaminophen)
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
Class III · Low risk
Midol Complete
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.
Class III · Low risk
Midol Complete
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.
Class II · Moderate risk
Meloxicam Tablets
Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
Class II · Moderate risk
Arthrotec 75
Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.
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