Pain Relief & OTC Medication Recalls

Recalls of common over-the-counter and prescription pain relievers.

415 recalls in this category, newest first.

Class III · Low risk Terminated Feb 2, 2018

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.

Allergan NDC 0023-6022-01 D-0413-2018

Class II · Moderate risk Terminated Jan 25, 2018

PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50…

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 55289-673-24 D-0341-2018

Class II · Moderate risk Terminated Jan 11, 2018

Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 53943-292-15 D-0695-2018

Class II · Moderate risk Terminated Jan 11, 2018

Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 49483-600-05 D-0694-2018

Class II · Moderate risk Terminated Jan 11, 2018

Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 42582-113-10 D-0693-2018

Class II · Moderate risk Terminated Jan 11, 2018

Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 49483-604-01 D-0692-2018

Class II · Moderate risk Terminated Jan 11, 2018

Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 42582-112-01 D-0691-2018

Class II · Moderate risk Terminated Jan 11, 2018

Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 42582-112-10 D-0690-2018

Class II · Moderate risk Terminated Jan 11, 2018

Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 49483-603-01 D-0689-2018

Class II · Moderate risk Terminated Jan 11, 2018

Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 42582-111-18 D-0688-2018

Class II · Moderate risk Terminated Jan 11, 2018

Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 49483-602-01 D-0687-2018

Class II · Moderate risk Terminated Jan 11, 2018

Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 53943-291-15 D-0686-2018

Class II · Moderate risk Terminated Jan 11, 2018

Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 49483-601-05 D-0685-2018

Class II · Moderate risk Terminated Jan 10, 2018

Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC…

Reason CGMP deviations: Ibuprofen is being recalled in response to previous recall

Spirit Pharmaceuticals, LLC NDC 68210-0800-1 D-0583-2018

Class II · Moderate risk Terminated Jan 9, 2018

Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Marksans Pharma Inc. NDC 25000-123-27 D-0240-2018

Class II · Moderate risk Terminated Jan 9, 2018

Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Marksans Pharma Inc. NDC 25000-122-28 D-0239-2018

Class II · Moderate risk Terminated Jan 9, 2018

Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Marksans Pharma Inc. NDC 25000-121-29 D-0238-2018

Class II · Moderate risk Terminated Jan 9, 2018

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Marksans Pharma Inc. NDC 25000-114-30 D-0237-2018

Class II · Moderate risk Terminated Jan 9, 2018

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Marksans Pharma Inc. NDC 25000-136-20 D-0236-2018

Class II · Moderate risk Terminated Jan 9, 2018

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further…

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Marksans Pharma Inc. NDC 25000-117-30 D-0235-2018

Class III · Low risk Terminated Dec 15, 2017

Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal…

Reason CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.

Akorn Inc D-0211-2018

Class II · Moderate risk Terminated Dec 4, 2017

Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC…

Reason Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg

Solco Healtcare US LLC NDC 43547-0333-50 D-0155-2018

Class III · Low risk Terminated Nov 10, 2017

Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown…

Reason Failed Stability Specifications

Bayer HealthCare Pharmaceuticals, Inc. NDC 0280-2160-36 D-0135-2018

Class III · Low risk Terminated Sep 22, 2017

Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals…

Reason Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.

Boehringer Ingelheim Pharmaceuticals, Inc. NDC 0597-0030-01 D-0007-2018

Class II · Moderate risk Terminated Aug 22, 2017

Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL)…

Reason Microbial contamination of Non-sterile Products; potential B. cepacia contamination

Centurion Labs, LLC NDC 23359-033-16 D-1141-2017

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